Simultaneous Assay of Teneligliptin and Pioglitazone in Bulk and Combined Formulations by a Validated RP-HPLC Method
Abstract
A reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed to simultaneously determine Teneligliptin and Pioglitazone in their combined dosage form. Both the analytes were separated on a C18 column (4.6x250mm, 5µm) with a mobile phase comprising acetonitrile: 5 mM phosphate buffer (pH 4.8) [65 35 v/v] at a flow rate of 0.5ml/min and PDA detection at 254nm. The method was applied successfully to analyze stressed samples without any interference with the peaks of the primary analytes. The method was validated for various parameters to comply with the ICH Q2(R) requirements. The method is sensitive with a quantitation limit of 2.243 µg/ml and 4.757 µg/ml for Teneligliptin and Pioglitazone, respectively and is suitable for routine quality control of the drugs in pharmaceutical dosage forms.
Keywords:
HPLC, ICH Guidelines, Pioglitazone, Stress Study, Teneligliptin, Validation
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References
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Baertschi, S.W., Alsante, K.M., & Reed, R.A. (Eds.). (2011). Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (2nd ed.). CRC Press. https://doi.org/10.3109/9781439801802
Biswas, B., Kumar, M., Sharma, J. B., Saini, V., & Bhatt, S. (2020). Method development and validation for estimation of teneligliptin in tablet dosage form by RP-HPLC. Research Journal of Pharmacy and Technology, 13(4), 1774-1778. https://doi.org/10.5958/0974-360X.2020.00320.0
Central Drugs Standard Control Organization (CDSCO). (2022). Marketing approval FDC 01.01.2022 to 25.11.2022. CDSCO 2022; chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalMarketingFDC/fdc01.01.2022%20to%2025.08.2022.pdf
Chhipa, A. S., Verma, S., & Patel, S. (2024). Type 2 diabetes mellitus: Novel targets and multitarget-directed phytotherapy. In Antidiabetic Medicinal Plants (pp. 385-408). Academic Press. https://doi.org/10.1016/B978-0-323-95719-9.00008-2
Dong, M. W. (2006). Modern HPLC for practicing scientists. John Wiley & Sons. https://download.e-bookshelf.de/download/0000/5855/65/L-G-0000585565-0002361539.pdf
Ermer, J., & Nethercote, P. W. (Eds.). (2025). Method validation in pharmaceutical analysis: A guide to best practice. John Wiley & Sons. 544 pages. https://www.wiley.com/en-kr/Method+Validation+in+Pharmaceutical+Analysis%3A+A+Guide+to+Best+Practice%2C+3rd+Edition-p-9783527831715
Godase, S. N., Vikhe, K. B., Kolhe, M. H., Mhaske, S. B., Bhor, R. J., & Gawali, P. S. (2024). Stability indicating method development and validation of teneligliptin by UHPLC method in bulk and pharmaceutical dosage form. International Journal of Pharmaceutical Investigation, 14(2). https://doi.org/10.5530/ijpi.14.2.70
ICH, I. (2005, November). Q2 (R1): Validation of analytical procedures: text and methodology. In International conference on harmonization, Geneva (Vol. 2005). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r1-validation-analytical-procedures-text-methodology-step-5-first-version_en.pdf
ICH (2003). Stability testing of new drug substances and products. Q1A(R2), current step 4(1–24). https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
Kadowaki, T., & Kondo, K. (2013). Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus. Journal of Diabetes Investigation, 4(6), 576-584. https://doi.org/10.1111/jdi.12092
Kumar, V. K., Sudhakar, M., Reddy, P. Y., Swapna, A., & Sekhar, R. V. (2011). Method development and validation for simultaneous estimation of pioglitazone and glimepiride in tablet dosage form by RP-HPLC and UV-spectrophotometric method. Journal of Current Pharma Research, 2(1), 404-410. https://jcpr.humanjournals.com/wp-content/uploads/2021/02/6.Vinod-Kumar-K-Sudhakar-M-Padmanabha-Reddy-Y-Swapna-A-Rajani-Sekhar-V..pdf
Kumar, V. N., Konyala, S. R., Bandaru, S. S., & Puchchakayala, G. (2019). Comparison of efficacy of add-on therapy of teneligliptin versus pioglitazone among type 2 diabetes mellitus patients ineptly controlled on dual therapy of metformin plus sulfonylurea. Journal of Diabetology, 10(2), 76-82. https://doi.org/10.4103/jod.jod_24_18
Marchand, D. K., Subramonian, A., Featherstone, R., & Spry, C. (2020). Pioglitazone for Type 2 Diabetes Mellitus and Pre-Diabetes: A Review of Safety. Canadian Agency for Drugs and Technologies in Health. https://www.cda-amc.ca/sites/default/files/pdf/htis/2020/RC1285%20Pioglitazone%20AE%20Final.pdf
Maruthi, R., Chandan, R. S., Barath, M., Datta, G. N., D'silva, M., Kumari, M. K., ... & Geetha, R. (2020). Analytical method development and validation of teneligliptin by rp-uflc. Research Journal of Pharmacy and Technology, 13(9), 4035-4040. https://doi.org/10.5958/0974-360X.2021.00014.7
Mota-Lugo, E., Dolores-Hernández, M., Morales-Hipólito, E. A., Blanco-Alcántara, I. A., Cuatecontzi-Flores, H., & López-Arellano, R. (2021). Development and validation of a stability‐indicating HPLC method for the simultaneous determination of trans‐resveratrol and cis‐resveratrol in an injectable solution. Journal of Analytical Methods in Chemistry, 2021(1), 8402157. https://doi.org/10.1155/2021/8402157
Nagarajan, K., Goel, R., Bhardwaj, A., & Grover, P. (2024). Development and validation of fast and sensitive RP-HPLC stability indicating method for quantification of teneligliptin in bulk drug. Journal of Chromatographic Science, 62(5), 483-491. https://doi.org/10.1093/chromsci/bmad061
Pandya, S., & Vekaria, H. J. (2025). Analytical Methods for Estimating Metformin Hydrochloride, Pioglitazone and Teneligliptin in Diabetes Management: a Comprehensive Review. Journal of Chromatographic Science, 63(3), bmaf013. https://doi.org/10.1093/chromsci/bmaf013
Pradhan, D., Sahu, P. K., Purohit, S., Ranajit, S. K., Acharya, B., Sangam, S., & Shrivastava, A. K. (2025). Therapeutic interventions for diabetes mellitus-associated complications. Current Diabetes Reviews, 21(8), e030524229631. https://doi.org/10.2174/0115733998291870240408043837
Prajapati, P., Rana, B., Pulusu, V. S., & Shah, S. (2023). Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: incorporating hybrid principles of white analytical chemistry and design of experiments. Future Journal of Pharmaceutical Sciences, 9(1), 1-15. https://doi.org/10.1186/s43094-023-00546-5
Reddy, G. R. K., & Rao, V. S. N. (2012). Development and validation of stability indicating assay method for pioglitazone drug substance by reverse phase HPLC. Journal of Global Trends in Pharmaceutical Sciences, 3(2), 584-596. https://jgtps.com/admin/uploads/COSvbG.pdf
Sen, A. K., Bhimani, N., Sen, D. B., Maheshwari, R. A., Gohil, D., & Koradia, S. K. (2024). Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet. Separation Science Plus, 7(1), 2300139. https://doi.org/10.1002/sscp.202300139
Shaikh, P. A., & Singla, N. (2025, March). Stability indicating method development of metformin, teneligliptin and pioglitazone in marketed formulation by HPLC. International Journal of Drug Delivery Technology, 15(1), 296-301. https://impactfactor.org/PDF/IJDDT/15/IJDDT,Vol15,Issue1,Article41.pdf
Sharma, S. K., Panneerselvam, A., Singh, K. P., Parmar, G., Gadge, P., & Swami, O. C. (2016). Teneligliptin in management of type 2 diabetes mellitus. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 251-260. https://doi.org/10.2147/DMSO.S106133
Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to modern liquid chromatography. John Wiley & Sons. https://onlinelibrary.wiley.com/doi/book/10.1002/9780470508183
Souri, E., Jalalizadeh, H., & Saremi, S. (2008). Development and validation of a simple and rapid HPLC method for determination of pioglitazone in human plasma and its application to a pharmacokinetic study. Journal of Chromatographic Science, 46(9), 809-812. https://doi.org/10.1093/chromsci/46.9.809
Tripathy, S., Sahu, P. K., Kumar, B. V. V. R., Acharya, B., & Mishra, D. P. (2023). An integrated hplc assay technique for the detection of omeprazole in mixed dose forms with aspirin, diclofenac or domperidone. Asian Journal of Chemistry. 35(2), 417–421. https://doi.org/10.14233/ajchem.2023.26930
Vijayasri, K. (2025). Analytical method development and validation for simultaneous estimation of teneligliptin and pioglitazone in pharmaceutical dosage forms by HPLC. World Journal of Pharmaceutical Sciences. 13(01), 18-25. https://doi.org/10.54037/WJPS.2022.100905
Vinay, T., Lalitha, N., & Mubeen, G. (2025). Development and validation of RP HPLC method for simultaneous estimation of teneligliptin and pioglitazone in tablet formulation. Asian Journal of Pharmaceutical Research and Development, 12(6), 31–36. https://doi.org/10.22270/ajprd.v12i6.1456
Association, A. D. (2021). 1. Improving care and promoting health in populations: Standards of Medical Care in Diabetes—2021. Diabetes Care, 44(Supplement_1), S7-S14. https://doi.org/10.2337/dc21-S001
Atlas, D. (2015). International diabetes federation. IDF Diabetes Atlas, 7th ed. Brussels, Belgium: International Diabetes Federation, 33(2). https://diabetesatlas.org/media/uploads/sites/3/2025/02/IDF-Atlas-2nd-Edition.pdf
Baertschi, S.W., Alsante, K.M., & Reed, R.A. (Eds.). (2011). Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (2nd ed.). CRC Press. https://doi.org/10.3109/9781439801802
Biswas, B., Kumar, M., Sharma, J. B., Saini, V., & Bhatt, S. (2020). Method development and validation for estimation of teneligliptin in tablet dosage form by RP-HPLC. Research Journal of Pharmacy and Technology, 13(4), 1774-1778. https://doi.org/10.5958/0974-360X.2020.00320.0
Central Drugs Standard Control Organization (CDSCO). (2022). Marketing approval FDC 01.01.2022 to 25.11.2022. CDSCO 2022; chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalMarketingFDC/fdc01.01.2022%20to%2025.08.2022.pdf
Chhipa, A. S., Verma, S., & Patel, S. (2024). Type 2 diabetes mellitus: Novel targets and multitarget-directed phytotherapy. In Antidiabetic Medicinal Plants (pp. 385-408). Academic Press. https://doi.org/10.1016/B978-0-323-95719-9.00008-2
Dong, M. W. (2006). Modern HPLC for practicing scientists. John Wiley & Sons. https://download.e-bookshelf.de/download/0000/5855/65/L-G-0000585565-0002361539.pdf
Ermer, J., & Nethercote, P. W. (Eds.). (2025). Method validation in pharmaceutical analysis: A guide to best practice. John Wiley & Sons. 544 pages. https://www.wiley.com/en-kr/Method+Validation+in+Pharmaceutical+Analysis%3A+A+Guide+to+Best+Practice%2C+3rd+Edition-p-9783527831715
Godase, S. N., Vikhe, K. B., Kolhe, M. H., Mhaske, S. B., Bhor, R. J., & Gawali, P. S. (2024). Stability indicating method development and validation of teneligliptin by UHPLC method in bulk and pharmaceutical dosage form. International Journal of Pharmaceutical Investigation, 14(2). https://doi.org/10.5530/ijpi.14.2.70
ICH, I. (2005, November). Q2 (R1): Validation of analytical procedures: text and methodology. In International conference on harmonization, Geneva (Vol. 2005). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r1-validation-analytical-procedures-text-methodology-step-5-first-version_en.pdf
ICH (2003). Stability testing of new drug substances and products. Q1A(R2), current step 4(1–24). https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
Kadowaki, T., & Kondo, K. (2013). Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus. Journal of Diabetes Investigation, 4(6), 576-584. https://doi.org/10.1111/jdi.12092
Kumar, V. K., Sudhakar, M., Reddy, P. Y., Swapna, A., & Sekhar, R. V. (2011). Method development and validation for simultaneous estimation of pioglitazone and glimepiride in tablet dosage form by RP-HPLC and UV-spectrophotometric method. Journal of Current Pharma Research, 2(1), 404-410. https://jcpr.humanjournals.com/wp-content/uploads/2021/02/6.Vinod-Kumar-K-Sudhakar-M-Padmanabha-Reddy-Y-Swapna-A-Rajani-Sekhar-V..pdf
Kumar, V. N., Konyala, S. R., Bandaru, S. S., & Puchchakayala, G. (2019). Comparison of efficacy of add-on therapy of teneligliptin versus pioglitazone among type 2 diabetes mellitus patients ineptly controlled on dual therapy of metformin plus sulfonylurea. Journal of Diabetology, 10(2), 76-82. https://doi.org/10.4103/jod.jod_24_18
Marchand, D. K., Subramonian, A., Featherstone, R., & Spry, C. (2020). Pioglitazone for Type 2 Diabetes Mellitus and Pre-Diabetes: A Review of Safety. Canadian Agency for Drugs and Technologies in Health. https://www.cda-amc.ca/sites/default/files/pdf/htis/2020/RC1285%20Pioglitazone%20AE%20Final.pdf
Maruthi, R., Chandan, R. S., Barath, M., Datta, G. N., D'silva, M., Kumari, M. K., ... & Geetha, R. (2020). Analytical method development and validation of teneligliptin by rp-uflc. Research Journal of Pharmacy and Technology, 13(9), 4035-4040. https://doi.org/10.5958/0974-360X.2021.00014.7
Mota-Lugo, E., Dolores-Hernández, M., Morales-Hipólito, E. A., Blanco-Alcántara, I. A., Cuatecontzi-Flores, H., & López-Arellano, R. (2021). Development and validation of a stability‐indicating HPLC method for the simultaneous determination of trans‐resveratrol and cis‐resveratrol in an injectable solution. Journal of Analytical Methods in Chemistry, 2021(1), 8402157. https://doi.org/10.1155/2021/8402157
Nagarajan, K., Goel, R., Bhardwaj, A., & Grover, P. (2024). Development and validation of fast and sensitive RP-HPLC stability indicating method for quantification of teneligliptin in bulk drug. Journal of Chromatographic Science, 62(5), 483-491. https://doi.org/10.1093/chromsci/bmad061
Pandya, S., & Vekaria, H. J. (2025). Analytical Methods for Estimating Metformin Hydrochloride, Pioglitazone and Teneligliptin in Diabetes Management: a Comprehensive Review. Journal of Chromatographic Science, 63(3), bmaf013. https://doi.org/10.1093/chromsci/bmaf013
Pradhan, D., Sahu, P. K., Purohit, S., Ranajit, S. K., Acharya, B., Sangam, S., & Shrivastava, A. K. (2025). Therapeutic interventions for diabetes mellitus-associated complications. Current Diabetes Reviews, 21(8), e030524229631. https://doi.org/10.2174/0115733998291870240408043837
Prajapati, P., Rana, B., Pulusu, V. S., & Shah, S. (2023). Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: incorporating hybrid principles of white analytical chemistry and design of experiments. Future Journal of Pharmaceutical Sciences, 9(1), 1-15. https://doi.org/10.1186/s43094-023-00546-5
Reddy, G. R. K., & Rao, V. S. N. (2012). Development and validation of stability indicating assay method for pioglitazone drug substance by reverse phase HPLC. Journal of Global Trends in Pharmaceutical Sciences, 3(2), 584-596. https://jgtps.com/admin/uploads/COSvbG.pdf
Sen, A. K., Bhimani, N., Sen, D. B., Maheshwari, R. A., Gohil, D., & Koradia, S. K. (2024). Densitometric simultaneous assessment of teneligliptin hydrobromide and pioglitazone hydrochloride in combined tablet. Separation Science Plus, 7(1), 2300139. https://doi.org/10.1002/sscp.202300139
Shaikh, P. A., & Singla, N. (2025, March). Stability indicating method development of metformin, teneligliptin and pioglitazone in marketed formulation by HPLC. International Journal of Drug Delivery Technology, 15(1), 296-301. https://impactfactor.org/PDF/IJDDT/15/IJDDT,Vol15,Issue1,Article41.pdf
Sharma, S. K., Panneerselvam, A., Singh, K. P., Parmar, G., Gadge, P., & Swami, O. C. (2016). Teneligliptin in management of type 2 diabetes mellitus. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 251-260. https://doi.org/10.2147/DMSO.S106133
Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to modern liquid chromatography. John Wiley & Sons. https://onlinelibrary.wiley.com/doi/book/10.1002/9780470508183
Souri, E., Jalalizadeh, H., & Saremi, S. (2008). Development and validation of a simple and rapid HPLC method for determination of pioglitazone in human plasma and its application to a pharmacokinetic study. Journal of Chromatographic Science, 46(9), 809-812. https://doi.org/10.1093/chromsci/46.9.809
Tripathy, S., Sahu, P. K., Kumar, B. V. V. R., Acharya, B., & Mishra, D. P. (2023). An integrated hplc assay technique for the detection of omeprazole in mixed dose forms with aspirin, diclofenac or domperidone. Asian Journal of Chemistry. 35(2), 417–421. https://doi.org/10.14233/ajchem.2023.26930
Vijayasri, K. (2025). Analytical method development and validation for simultaneous estimation of teneligliptin and pioglitazone in pharmaceutical dosage forms by HPLC. World Journal of Pharmaceutical Sciences. 13(01), 18-25. https://doi.org/10.54037/WJPS.2022.100905
Vinay, T., Lalitha, N., & Mubeen, G. (2025). Development and validation of RP HPLC method for simultaneous estimation of teneligliptin and pioglitazone in tablet formulation. Asian Journal of Pharmaceutical Research and Development, 12(6), 31–36. https://doi.org/10.22270/ajprd.v12i6.1456
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Tripathy, S., Sahu, P., Panda, S., & Kumar, B. (2026). Simultaneous Assay of Teneligliptin and Pioglitazone in Bulk and Combined Formulations by a Validated RP-HPLC Method. International Journal of Advancement in Life Sciences Research, 9(1), 72-81. https://doi.org/https://doi.org/10.31632/ijalsr.2026.v09i01.005
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