Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin
Abstract Background The CDSCO of India has authorized a combination of metformin hydrochloride, teneligliptin hydrochloride, and pioglitazone hydrochloride for the treatment of insulin-independent diabetes. For the purpose of estimating metformin, teneligliptin, and pioglitazone combinations as well...
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| Format: | Article |
| Language: | English |
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SpringerOpen
2024-11-01
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| Series: | Future Journal of Pharmaceutical Sciences |
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| Online Access: | https://doi.org/10.1186/s43094-024-00746-7 |
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| author | Pintu Prajapati Pooja Patel Dhrumi Naik Anzarul Haque Shailesh Shah |
| author_facet | Pintu Prajapati Pooja Patel Dhrumi Naik Anzarul Haque Shailesh Shah |
| author_sort | Pintu Prajapati |
| collection | DOAJ |
| description | Abstract Background The CDSCO of India has authorized a combination of metformin hydrochloride, teneligliptin hydrochloride, and pioglitazone hydrochloride for the treatment of insulin-independent diabetes. For the purpose of estimating metformin, teneligliptin, and pioglitazone combinations as well as individual commercial formulations, there are a plethora of publicly accessible chromatographic techniques. More importantly, the development of these chromatographic procedures has included the use of chemical solvents that are dangerous to both animals and the environment. Objectives However, to date, there has been no documented chromatographic technique that can concomitantly estimate various commercial formulations of drugs under study employing a uniform chromatographic condition and environmentally friendly solvents. In order to concomitantly estimate drugs under study utilizing unified chromatographic conditions, a green HPTLC method was developed. Method The AQbD approach was used to carry out the method development. To determine the most important method parameters and response variables, the analytical risk assessment was conducted using the risk priority number ranking and screening approach. Critical method parameters and response variables were modeled using the response surface modeling approach, which relies on the central composite design. Optimal ranges for the intended method operable design region were determined, and control strategy was framed. The chromatographic separation was carried out on preparative TLC plate precoated with silica gel G-60 F254 using 1.0%W/V ammonium acetate in ethanol: water: triethylamine (6.5:0.4:0.6, V/V) as mobile phase. The detection of the anti-diabetic drugs under study was carried out at 267 nm wavelength. Results The linearity of metformin, teneligliptin, and pioglitazone was found to be 5000–25000 ng/band, 200–1000 ng/band, and 150–750 ng/band, respectively. The %RSD for robustness and precision study was found to be less than 2.0%. The %recovery of method was found to be 98–102%. The assay results were shown to be in compliance with respective labeled claims of anti-diabetic medications when the suggested method was used for concurrent analysis of several formulations and combinations of drugs under study. Conclusion The suggested technique was evaluated utilizing red–green–blue model scoring tools. The suggested technique was determined to be precise, accurate, rapid, cost-effective, and easy to apply for the estimation of drugs under study. |
| format | Article |
| id | doaj-art-df65f63511d840ce94de79c006772bb9 |
| institution | OA Journals |
| issn | 2314-7253 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | SpringerOpen |
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| series | Future Journal of Pharmaceutical Sciences |
| spelling | doaj-art-df65f63511d840ce94de79c006772bb92025-08-20T02:08:15ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532024-11-0110111710.1186/s43094-024-00746-7Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptinPintu Prajapati0Pooja Patel1Dhrumi Naik2Anzarul Haque3Shailesh Shah4Department of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia UniversityDepartment of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia UniversityDepartment of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia UniversityCentral Laboratories Unit, Qatar UniversityDepartment of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia UniversityAbstract Background The CDSCO of India has authorized a combination of metformin hydrochloride, teneligliptin hydrochloride, and pioglitazone hydrochloride for the treatment of insulin-independent diabetes. For the purpose of estimating metformin, teneligliptin, and pioglitazone combinations as well as individual commercial formulations, there are a plethora of publicly accessible chromatographic techniques. More importantly, the development of these chromatographic procedures has included the use of chemical solvents that are dangerous to both animals and the environment. Objectives However, to date, there has been no documented chromatographic technique that can concomitantly estimate various commercial formulations of drugs under study employing a uniform chromatographic condition and environmentally friendly solvents. In order to concomitantly estimate drugs under study utilizing unified chromatographic conditions, a green HPTLC method was developed. Method The AQbD approach was used to carry out the method development. To determine the most important method parameters and response variables, the analytical risk assessment was conducted using the risk priority number ranking and screening approach. Critical method parameters and response variables were modeled using the response surface modeling approach, which relies on the central composite design. Optimal ranges for the intended method operable design region were determined, and control strategy was framed. The chromatographic separation was carried out on preparative TLC plate precoated with silica gel G-60 F254 using 1.0%W/V ammonium acetate in ethanol: water: triethylamine (6.5:0.4:0.6, V/V) as mobile phase. The detection of the anti-diabetic drugs under study was carried out at 267 nm wavelength. Results The linearity of metformin, teneligliptin, and pioglitazone was found to be 5000–25000 ng/band, 200–1000 ng/band, and 150–750 ng/band, respectively. The %RSD for robustness and precision study was found to be less than 2.0%. The %recovery of method was found to be 98–102%. The assay results were shown to be in compliance with respective labeled claims of anti-diabetic medications when the suggested method was used for concurrent analysis of several formulations and combinations of drugs under study. Conclusion The suggested technique was evaluated utilizing red–green–blue model scoring tools. The suggested technique was determined to be precise, accurate, rapid, cost-effective, and easy to apply for the estimation of drugs under study.https://doi.org/10.1186/s43094-024-00746-7Metformin hydrochlorideTeneligliptin hydrobromide hydratePioglitazone hydrochlorideAnalytical quality by designResponse surface modeling |
| spellingShingle | Pintu Prajapati Pooja Patel Dhrumi Naik Anzarul Haque Shailesh Shah Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin Future Journal of Pharmaceutical Sciences Metformin hydrochloride Teneligliptin hydrobromide hydrate Pioglitazone hydrochloride Analytical quality by design Response surface modeling |
| title | Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin |
| title_full | Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin |
| title_fullStr | Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin |
| title_full_unstemmed | Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin |
| title_short | Red, green, and blue model assessment and AQbD approach to HPTLC method for concomitant analysis of metformin, pioglitazone, and teneligliptin |
| title_sort | red green and blue model assessment and aqbd approach to hptlc method for concomitant analysis of metformin pioglitazone and teneligliptin |
| topic | Metformin hydrochloride Teneligliptin hydrobromide hydrate Pioglitazone hydrochloride Analytical quality by design Response surface modeling |
| url | https://doi.org/10.1186/s43094-024-00746-7 |
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