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…
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