Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach

Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatogra...
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Autor*in:	Prajapati, Pintu [verfasserIn] Patel, Shruti [verfasserIn] Mishra, Ashish [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	Quality risk management Design of experiment Plackett‒Burman design Box‒Behnken design Method operable design region

Übergeordnetes Werk:	Enthalten in: Journal of planar chromatography, modern TLC - Budapest : Akadémiai Kiadó, 2001, 33(2020), 6 vom: Dez., Seite 631-646
Übergeordnetes Werk:	volume:33 ; year:2020 ; number:6 ; month:12 ; pages:631-646

Links:	Volltext

DOI / URN:	10.1007/s00764-020-00067-4

Katalog-ID:	SPR043181058

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520			\|a Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.
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912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_138
912			\|a GBV_ILN_150
912			\|a GBV_ILN_151
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912			\|a GBV_ILN_2027
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912			\|a GBV_ILN_2034
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912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2065
912			\|a GBV_ILN_2068
912			\|a GBV_ILN_2088
912			\|a GBV_ILN_2093
912			\|a GBV_ILN_2106
912			\|a GBV_ILN_2107
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912			\|a GBV_ILN_2110
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allfields	10.1007/s00764-020-00067-4 doi (DE-627)SPR043181058 (DE-599)SPRs00764-020-00067-4-e (SPR)s00764-020-00067-4-e DE-627 ger DE-627 rakwb eng 540 530 ASE Prajapati, Pintu verfasserin aut Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim. Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213 Patel, Shruti verfasserin aut Mishra, Ashish verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 33(2020), 6 vom: Dez., Seite 631-646 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:33 year:2020 number:6 month:12 pages:631-646 https://dx.doi.org/10.1007/s00764-020-00067-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 33 2020 6 12 631-646
spelling	10.1007/s00764-020-00067-4 doi (DE-627)SPR043181058 (DE-599)SPRs00764-020-00067-4-e (SPR)s00764-020-00067-4-e DE-627 ger DE-627 rakwb eng 540 530 ASE Prajapati, Pintu verfasserin aut Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim. Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213 Patel, Shruti verfasserin aut Mishra, Ashish verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 33(2020), 6 vom: Dez., Seite 631-646 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:33 year:2020 number:6 month:12 pages:631-646 https://dx.doi.org/10.1007/s00764-020-00067-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 33 2020 6 12 631-646
allfields_unstemmed	10.1007/s00764-020-00067-4 doi (DE-627)SPR043181058 (DE-599)SPRs00764-020-00067-4-e (SPR)s00764-020-00067-4-e DE-627 ger DE-627 rakwb eng 540 530 ASE Prajapati, Pintu verfasserin aut Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim. Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213 Patel, Shruti verfasserin aut Mishra, Ashish verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 33(2020), 6 vom: Dez., Seite 631-646 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:33 year:2020 number:6 month:12 pages:631-646 https://dx.doi.org/10.1007/s00764-020-00067-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 33 2020 6 12 631-646
allfieldsGer	10.1007/s00764-020-00067-4 doi (DE-627)SPR043181058 (DE-599)SPRs00764-020-00067-4-e (SPR)s00764-020-00067-4-e DE-627 ger DE-627 rakwb eng 540 530 ASE Prajapati, Pintu verfasserin aut Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim. Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213 Patel, Shruti verfasserin aut Mishra, Ashish verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 33(2020), 6 vom: Dez., Seite 631-646 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:33 year:2020 number:6 month:12 pages:631-646 https://dx.doi.org/10.1007/s00764-020-00067-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 33 2020 6 12 631-646
allfieldsSound	10.1007/s00764-020-00067-4 doi (DE-627)SPR043181058 (DE-599)SPRs00764-020-00067-4-e (SPR)s00764-020-00067-4-e DE-627 ger DE-627 rakwb eng 540 530 ASE Prajapati, Pintu verfasserin aut Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim. Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213 Patel, Shruti verfasserin aut Mishra, Ashish verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 33(2020), 6 vom: Dez., Seite 631-646 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:33 year:2020 number:6 month:12 pages:631-646 https://dx.doi.org/10.1007/s00764-020-00067-4 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 33 2020 6 12 631-646
language	English
source	Enthalten in Journal of planar chromatography, modern TLC 33(2020), 6 vom: Dez., Seite 631-646 volume:33 year:2020 number:6 month:12 pages:631-646
sourceStr	Enthalten in Journal of planar chromatography, modern TLC 33(2020), 6 vom: Dez., Seite 631-646 volume:33 year:2020 number:6 month:12 pages:631-646
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Quality risk management Design of experiment Plackett‒Burman design Box‒Behnken design Method operable design region
dewey-raw	540
isfreeaccess_bool	false
container_title	Journal of planar chromatography, modern TLC
authorswithroles_txt_mv	Prajapati, Pintu @@aut@@ Patel, Shruti @@aut@@ Mishra, Ashish @@aut@@
publishDateDaySort_date	2020-12-01T00:00:00Z
hierarchy_top_id	529764563
dewey-sort	3540
id	SPR043181058
language_de	englisch
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author	Prajapati, Pintu
spellingShingle	Prajapati, Pintu ddc 540 misc Quality risk management misc Design of experiment misc Plackett‒Burman design misc Box‒Behnken design misc Method operable design region Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
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topic_title	540 530 ASE Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach Quality risk management (dpeaa)DE-He213 Design of experiment (dpeaa)DE-He213 Plackett‒Burman design (dpeaa)DE-He213 Box‒Behnken design (dpeaa)DE-He213 Method operable design region (dpeaa)DE-He213
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title	Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
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title_full	Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
author_sort	Prajapati, Pintu
journal	Journal of planar chromatography, modern TLC
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author_browse	Prajapati, Pintu Patel, Shruti Mishra, Ashish
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title_sort	simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
title_auth	Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
abstract	Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.
abstractGer	Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.
abstract_unstemmed	Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. The developed method was applied for the assay of combined pharmaceutical dosage forms of AZM and CLT and the results were found in good agreement with their labelled claim.
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title_short	Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach
url	https://dx.doi.org/10.1007/s00764-020-00067-4
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up_date	2024-07-03T17:03:50.176Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR043181058</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230520005336.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">210216s2020 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s00764-020-00067-4</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR043181058</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)SPRs00764-020-00067-4-e</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s00764-020-00067-4-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">540</subfield><subfield code="a">530</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Prajapati, Pintu</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimation of azilsartan medoxomil (AZM) and chlorthalidone (CLT) by the implementation of QRM- and DoE-based quality by design approach. QRM was performed by the identification of probable method risk parameters and their assessment by allotting a risk priority number. DoE was implemented by Placket-Burman screening design and Box-Behnken response surface analysis using Design-Expert software (trial version) by selecting resolution and tailing factor as critical method attributes. Method operable design region (MODR) was navigated for development of the method as per the analytical target profile (ATP). Chromatographic separation was performed using silica gel $ GF_{254} $ as the stationary phase and toluene‒methanol‒ethyl acetate‒formic acid (7:2:1:0.2, V/V) as the mobile phase in twin-trough chamber keeping a saturation time of 15 min. The developed method was validated as per the International Conference on Harmonization Q2 (R1) guideline. 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Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach

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