Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design

Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and...
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Autor*in:	Patel, Khushbu [verfasserIn] Shah, Ujashkumar A. Patel, C. N.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Schlagwörter:	Analytical quality by design (AQbD) Box–Behnken Design of experimental (DOE) Evogliptin tartrate (EVO) Method validation RP-HPLC

Anmerkung:	© The Author(s) 2023

Übergeordnetes Werk:	Enthalten in: Future Journal of Pharmaceutical Sciences - Berlin : SpringerOpen, 2015, 9(2023), 1 vom: 19. Juli
Übergeordnetes Werk:	volume:9 ; year:2023 ; number:1 ; day:19 ; month:07

Links:	Volltext

DOI / URN:	10.1186/s43094-023-00509-w

Katalog-ID:	SPR052312933

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520			\|a Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate.
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allfields	10.1186/s43094-023-00509-w doi (DE-627)SPR052312933 (SPR)s43094-023-00509-w-e DE-627 ger DE-627 rakwb eng Patel, Khushbu verfasserin (orcid)0000-0002-8106-7711 aut Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213 Shah, Ujashkumar A. aut Patel, C. N. aut Enthalten in Future Journal of Pharmaceutical Sciences Berlin : SpringerOpen, 2015 9(2023), 1 vom: 19. Juli (DE-627)835143171 (DE-600)2834845-X 2314-7253 nnns volume:9 year:2023 number:1 day:19 month:07 https://dx.doi.org/10.1186/s43094-023-00509-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2023 1 19 07
spelling	10.1186/s43094-023-00509-w doi (DE-627)SPR052312933 (SPR)s43094-023-00509-w-e DE-627 ger DE-627 rakwb eng Patel, Khushbu verfasserin (orcid)0000-0002-8106-7711 aut Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213 Shah, Ujashkumar A. aut Patel, C. N. aut Enthalten in Future Journal of Pharmaceutical Sciences Berlin : SpringerOpen, 2015 9(2023), 1 vom: 19. Juli (DE-627)835143171 (DE-600)2834845-X 2314-7253 nnns volume:9 year:2023 number:1 day:19 month:07 https://dx.doi.org/10.1186/s43094-023-00509-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2023 1 19 07
allfields_unstemmed	10.1186/s43094-023-00509-w doi (DE-627)SPR052312933 (SPR)s43094-023-00509-w-e DE-627 ger DE-627 rakwb eng Patel, Khushbu verfasserin (orcid)0000-0002-8106-7711 aut Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213 Shah, Ujashkumar A. aut Patel, C. N. aut Enthalten in Future Journal of Pharmaceutical Sciences Berlin : SpringerOpen, 2015 9(2023), 1 vom: 19. Juli (DE-627)835143171 (DE-600)2834845-X 2314-7253 nnns volume:9 year:2023 number:1 day:19 month:07 https://dx.doi.org/10.1186/s43094-023-00509-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2023 1 19 07
allfieldsGer	10.1186/s43094-023-00509-w doi (DE-627)SPR052312933 (SPR)s43094-023-00509-w-e DE-627 ger DE-627 rakwb eng Patel, Khushbu verfasserin (orcid)0000-0002-8106-7711 aut Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213 Shah, Ujashkumar A. aut Patel, C. N. aut Enthalten in Future Journal of Pharmaceutical Sciences Berlin : SpringerOpen, 2015 9(2023), 1 vom: 19. Juli (DE-627)835143171 (DE-600)2834845-X 2314-7253 nnns volume:9 year:2023 number:1 day:19 month:07 https://dx.doi.org/10.1186/s43094-023-00509-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2023 1 19 07
allfieldsSound	10.1186/s43094-023-00509-w doi (DE-627)SPR052312933 (SPR)s43094-023-00509-w-e DE-627 ger DE-627 rakwb eng Patel, Khushbu verfasserin (orcid)0000-0002-8106-7711 aut Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213 Shah, Ujashkumar A. aut Patel, C. N. aut Enthalten in Future Journal of Pharmaceutical Sciences Berlin : SpringerOpen, 2015 9(2023), 1 vom: 19. Juli (DE-627)835143171 (DE-600)2834845-X 2314-7253 nnns volume:9 year:2023 number:1 day:19 month:07 https://dx.doi.org/10.1186/s43094-023-00509-w kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2023 1 19 07
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By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Analytical quality by design (AQbD)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Box–Behnken</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Design of experimental (DOE)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Evogliptin tartrate (EVO)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Method validation</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">RP-HPLC</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Shah, Ujashkumar A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Patel, C. 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author	Patel, Khushbu
spellingShingle	Patel, Khushbu misc Analytical quality by design (AQbD) misc Box–Behnken misc Design of experimental (DOE) misc Evogliptin tartrate (EVO) misc Method validation misc RP-HPLC Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design
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topic_title	Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design Analytical quality by design (AQbD) (dpeaa)DE-He213 Box–Behnken (dpeaa)DE-He213 Design of experimental (DOE) (dpeaa)DE-He213 Evogliptin tartrate (EVO) (dpeaa)DE-He213 Method validation (dpeaa)DE-He213 RP-HPLC (dpeaa)DE-He213
topic	misc Analytical quality by design (AQbD) misc Box–Behnken misc Design of experimental (DOE) misc Evogliptin tartrate (EVO) misc Method validation misc RP-HPLC
topic_unstemmed	misc Analytical quality by design (AQbD) misc Box–Behnken misc Design of experimental (DOE) misc Evogliptin tartrate (EVO) misc Method validation misc RP-HPLC
topic_browse	misc Analytical quality by design (AQbD) misc Box–Behnken misc Design of experimental (DOE) misc Evogliptin tartrate (EVO) misc Method validation misc RP-HPLC
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title	Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design
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title_full	Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design
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title_sort	box–behnken design-assisted optimization of rp-hplc method for the estimation of evogliptin tartrate by analytical quality by design
title_auth	Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design
abstract	Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. © The Author(s) 2023
abstractGer	Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. © The Author(s) 2023
abstract_unstemmed	Background A quality by design approach can potentially lead to a more robust/rugged method development due to emphasis on the risk assessment and management. By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate. © The Author(s) 2023
collection_details	GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_20 GBV_ILN_22 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700
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title_short	Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design
url	https://dx.doi.org/10.1186/s43094-023-00509-w
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author2	Shah, Ujashkumar A. Patel, C. N.
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By carefully understanding the step-by-step procedure for analytical QbD-based optimization parameters, such as analytical target profile and critical quality attributes (CQAs), was assessed. The present study describes the simple, rapid, sensitive and cost-effective RP-HPLC method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Results The factor screening studies were performed using Box–Behnken design by three key components of the RP-HPLC method (mobile phase, pH and flow rate). The chromatographic conditions were optimized with the Design Expert software trial version 13.0. The optimal chromatographic separation was achieved having water C18 column (250 mm × 4.6 mm, 5 μ) and using mobile phase as a methanol and phosphate buffer (pH 4.5) 60:40% v/v with a flow rate 1.0 ml/min and UV detection at 267 nm. The Box–Behnken experimental design describes the interrelationship of mobile phase, pH and flow rate at three different levels, and responses of retention time and tailing factor were observed with response surface plot and statistical data. The developed method was validated as per recommended ICH guidelines which revealed the high degree of linear, precise, accurate, sensitive and robust method over the existing RP-HPLC method for evogliptin tartrate. Conclusion The developed QbD-based method helped in generating a design space and operating space with knowledge of all method performance characteristics, and RP-HPLC method takes less time and can be used in the industry for routine quality control of bulk and marketed formulation of evogliptin tartrate.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Analytical quality by design (AQbD)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Box–Behnken</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Design of experimental (DOE)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Evogliptin tartrate (EVO)</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Method validation</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">RP-HPLC</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Shah, Ujashkumar A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Patel, C. N.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Future Journal of Pharmaceutical Sciences</subfield><subfield code="d">Berlin : SpringerOpen, 2015</subfield><subfield code="g">9(2023), 1 vom: 19. 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Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design

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