Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms

Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutic...
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Autor*in:	Prajapati, Pintu [verfasserIn] Gami, Abhay Shah, Shailesh

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	Analytical quality risk management Taguchi design DoE Central composite design Method operable design region (MODR)

Anmerkung:	© Springer Nature Switzerland AG 2020

Übergeordnetes Werk:	Enthalten in: SN applied sciences - [Cham] : Springer International Publishing, 2019, 2(2020), 2 vom: 30. Jan.
Übergeordnetes Werk:	volume:2 ; year:2020 ; number:2 ; day:30 ; month:01

Links:	Volltext

DOI / URN:	10.1007/s42452-020-2066-z

Katalog-ID:	SPR038583801

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520			\|a Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms.
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allfields	10.1007/s42452-020-2066-z doi (DE-627)SPR038583801 (SPR)s42452-020-2066-z-e DE-627 ger DE-627 rakwb eng Prajapati, Pintu verfasserin aut Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Nature Switzerland AG 2020 Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213 Gami, Abhay aut Shah, Shailesh aut Enthalten in SN applied sciences [Cham] : Springer International Publishing, 2019 2(2020), 2 vom: 30. Jan. (DE-627)103761139X (DE-600)2947292-1 2523-3971 nnns volume:2 year:2020 number:2 day:30 month:01 https://dx.doi.org/10.1007/s42452-020-2066-z 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_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 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_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_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_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 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_4367 GBV_ILN_4393 GBV_ILN_4700 AR 2 2020 2 30 01
spelling	10.1007/s42452-020-2066-z doi (DE-627)SPR038583801 (SPR)s42452-020-2066-z-e DE-627 ger DE-627 rakwb eng Prajapati, Pintu verfasserin aut Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Nature Switzerland AG 2020 Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213 Gami, Abhay aut Shah, Shailesh aut Enthalten in SN applied sciences [Cham] : Springer International Publishing, 2019 2(2020), 2 vom: 30. Jan. (DE-627)103761139X (DE-600)2947292-1 2523-3971 nnns volume:2 year:2020 number:2 day:30 month:01 https://dx.doi.org/10.1007/s42452-020-2066-z 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_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 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_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_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_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 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_4367 GBV_ILN_4393 GBV_ILN_4700 AR 2 2020 2 30 01
allfields_unstemmed	10.1007/s42452-020-2066-z doi (DE-627)SPR038583801 (SPR)s42452-020-2066-z-e DE-627 ger DE-627 rakwb eng Prajapati, Pintu verfasserin aut Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Nature Switzerland AG 2020 Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213 Gami, Abhay aut Shah, Shailesh aut Enthalten in SN applied sciences [Cham] : Springer International Publishing, 2019 2(2020), 2 vom: 30. Jan. (DE-627)103761139X (DE-600)2947292-1 2523-3971 nnns volume:2 year:2020 number:2 day:30 month:01 https://dx.doi.org/10.1007/s42452-020-2066-z 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_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 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_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_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_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 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_4367 GBV_ILN_4393 GBV_ILN_4700 AR 2 2020 2 30 01
allfieldsGer	10.1007/s42452-020-2066-z doi (DE-627)SPR038583801 (SPR)s42452-020-2066-z-e DE-627 ger DE-627 rakwb eng Prajapati, Pintu verfasserin aut Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Nature Switzerland AG 2020 Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213 Gami, Abhay aut Shah, Shailesh aut Enthalten in SN applied sciences [Cham] : Springer International Publishing, 2019 2(2020), 2 vom: 30. Jan. (DE-627)103761139X (DE-600)2947292-1 2523-3971 nnns volume:2 year:2020 number:2 day:30 month:01 https://dx.doi.org/10.1007/s42452-020-2066-z 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_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 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_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_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_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 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_4367 GBV_ILN_4393 GBV_ILN_4700 AR 2 2020 2 30 01
allfieldsSound	10.1007/s42452-020-2066-z doi (DE-627)SPR038583801 (SPR)s42452-020-2066-z-e DE-627 ger DE-627 rakwb eng Prajapati, Pintu verfasserin aut Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer Nature Switzerland AG 2020 Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213 Gami, Abhay aut Shah, Shailesh aut Enthalten in SN applied sciences [Cham] : Springer International Publishing, 2019 2(2020), 2 vom: 30. Jan. (DE-627)103761139X (DE-600)2947292-1 2523-3971 nnns volume:2 year:2020 number:2 day:30 month:01 https://dx.doi.org/10.1007/s42452-020-2066-z 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_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_138 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_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_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_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 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_4367 GBV_ILN_4393 GBV_ILN_4700 AR 2 2020 2 30 01
language	English
source	Enthalten in SN applied sciences 2(2020), 2 vom: 30. Jan. volume:2 year:2020 number:2 day:30 month:01
sourceStr	Enthalten in SN applied sciences 2(2020), 2 vom: 30. Jan. volume:2 year:2020 number:2 day:30 month:01
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Analytical quality risk management Taguchi design DoE Central composite design Method operable design region (MODR)
isfreeaccess_bool	false
container_title	SN applied sciences
authorswithroles_txt_mv	Prajapati, Pintu @@aut@@ Gami, Abhay @@aut@@ Shah, Shailesh @@aut@@
publishDateDaySort_date	2020-01-30T00:00:00Z
hierarchy_top_id	103761139X
id	SPR038583801
language_de	englisch
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author	Prajapati, Pintu
spellingShingle	Prajapati, Pintu misc Analytical quality risk management misc Taguchi design misc DoE misc Central composite design misc Method operable design region (MODR) Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
authorStr	Prajapati, Pintu
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topic_title	Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms Analytical quality risk management (dpeaa)DE-He213 Taguchi design (dpeaa)DE-He213 DoE (dpeaa)DE-He213 Central composite design (dpeaa)DE-He213 Method operable design region (MODR) (dpeaa)DE-He213
topic	misc Analytical quality risk management misc Taguchi design misc DoE misc Central composite design misc Method operable design region (MODR)
topic_unstemmed	misc Analytical quality risk management misc Taguchi design misc DoE misc Central composite design misc Method operable design region (MODR)
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title	Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
ctrlnum	(DE-627)SPR038583801 (SPR)s42452-020-2066-z-e
title_full	Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
author_sort	Prajapati, Pintu
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author_browse	Prajapati, Pintu Gami, Abhay Shah, Shailesh
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doi_str_mv	10.1007/s42452-020-2066-z
title_sort	analytical quality risk management and doe based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
title_auth	Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
abstract	Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. © Springer Nature Switzerland AG 2020
abstractGer	Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. © Springer Nature Switzerland AG 2020
abstract_unstemmed	Abstract Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were done with brainstorming process with help of ishikawa diagram and experimental results based risk factor priority number (RPN). Critical risk factors which having RPN number more than sixty were further analysed for their criticality in method development by DoE based Taguchi screening design. From seven critical risk factors, volume of methanol in mobile phase and migration distance were identified as highly risky factors for development of HPTLC method. DoE based central composite design was applied for risk factors analysis and mitigation by optimisation of identified high risk factors. After implementation of risk minimisation operable design region and control strategy were set for development of robust HPTLC method for simultaneous estimation of tizanidine hydrochloride and nimesulide. Developed analytical method was validated for specificity, linearity, accuracy, precision and LOD-LOQ as per ICH guideline Q2R1. Validated HPTLC method was applied for assay of combined marketed pharmaceutical dosage forms of both drugs and results were found in good agreement with labelled claim of dosage forms. © Springer Nature Switzerland AG 2020
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title_short	Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms
url	https://dx.doi.org/10.1007/s42452-020-2066-z
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author2	Gami, Abhay Shah, Shailesh
author2Str	Gami, Abhay Shah, Shailesh
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doi_str	10.1007/s42452-020-2066-z
up_date	2024-07-03T18:59:57.027Z
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Analytical quality risk management and DoE based development of robust chromatographic method for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms

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