Quality by Design (QbD) Based Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Teneligliptin in Bulk and their Pharmaceutical Formulation
1, 2, 2, 2, 2, 2
- 1Department of Pharmaceutical Chemistry and Quality Assurance, L. M. College of Pharmacy, Ahmedabad, Gujarat, INDIA.
- 2Faculty of Pharmacy, Dharmsinh Desai University, Nadiad, Gujarat, INDIA.
CORRESPONDENCE
Dr. Jagatkumar Upadhyay
Department of Pharmaceutical Chemistry and Quality Assurance, L. M. College of Pharmacy, Ahmedabad, Gujarat, INDIA.
Received: 18-03-2023; Revised: 30-07-2024; Accepted: 23-12-2024.
Volume 59, Issue 2s (Supplement) · pp. s689-s704 · 2025 · DOI: 10.5530/ijper.20253717
ABSTRACT
Aim: To develop and validate simple, accurate, precise, sensitive and robust Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous estimation of metformin and teneligliptin in bulk and their pharmaceutical formulation by using Quality by Design (QbD) approach.Materials and Methods: The factor screening studies were performed using 2 level 4 factor (16 run) full factorial design. C18 Gracesmart column (150×4.6 mm, 5 μ) was saturated with mobile phase acetate buffer pH 4: acetonitrile (56.4: 43.6 v/v). Mobile phase was pumped at flow rate 1 mL/min. Both the drugs metformin and teneligliptin detected by diode array detector at wavelength 250 nm.Results: Retention time for metformin and teneligliptin were found to be 1.983 min and 3.263 min respectively. Metformin and teneligliptin show linear response in concentration range 50-300 μg/mL and 2-12 μg/mL respectively. % Recovery for metformin and teneligliptin was found to be 100.15%-101.43% and 98.76%-99.48% respectively. In precision study % relative standard deviation was found less than 2 for metformin and teneligliptin. Limit of Detection (LOD) for metformin and teneligliptin was found to be 1.281 μg/ mL and 0.464 μg/mL respectively. Limit of Quantification (LOQ) for metformin and teneligliptin was found to be 3.881 μg/mL and 1.407 μg/mL respectively.Conclusion: The proposed method was found to be accurate, precise, sensitive and robust. As a result, it might be successfully employed for the routine analysis of metformin and teneligliptin in bulk and their pharmaceutical dosage forms.
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Upadhyay, J., Padhiyar, S., Jivani, K., Patel, T., Bhavsar, V., & Prajapati, V. (2025). Quality by Design (QbD) Based Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Teneligliptin in Bulk and their Pharmaceutical Formulation. Indian Journal of Pharmaceutical Education and Research, 59(2s), s689-s704. https://doi.org/10.5530/ijper.20253717
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