A Simple, Precise, and Sensitive RP-HPLC Method for Quantification of Teneligliptin Hydrobromide and Metformin Hydrochloride: Development and Validation

Abstract

Simple, rapid, sensitive, robust, and validated reverse phase- high-performance liquid chromatography RP_(HPLC) was developed for the quantification of anti-diabetic drugs Teneligliptin hydrobromide (TH) and Metformin hydrochloride (MH) in bulk and in formulation. The RP-HPLC method was developed using an HPLC system with a PDA detector. A simple, accurate and cost-effective gradient approach is used by using C18 Inertsil ODS (150×4.6)mm, 5µ. A method was developed and validated as per ICH Q2 (R1) guideline. The efficient separation of both drugs was achieved using an optimised solvent mixture of Buffer: ACN (85:15% v/v) and Methanol: ACN (50:50% v/v) used as a gradient mobile phase, during this experiments flow rate was maintained 0.8 ml/min and at the end the detection of peak carried out by PDA detector at wavelength 249nm. The method has been validated for TH and MH for a range of 16-64μg/ml and 400 - 1600μg/ml with regression coefficient (r2) was 1 and 0.9979 respectively. The optimal approach has been validated in accordance with ICH guideline Q2(R1). The results demonstrated that the method’s accuracy (99.89–100.34 percent w/w and 99.91–100.01 percent w / w TH and MH, respectively) and method is precise as percentage of relative standard deviation <2.0. The proposed LC method used as qualitative as well as quantitative applications for simultaneous quantification of Teneligliptin hydrobromide and Metformin hydrochloride in bulk and tablet dosage form and also sufficient to apply regulatory purpose.