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

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.

Keywords: Metformin; Teneligliptin; RP-HPLC; Quality by design (QbD) approach