Development and validation of RP-HPLC method for simultaneous estimation of teneliglipt in hydro bromide hydrate and glimepiride in bulk and tablet dosage form

Abstract

A novel RP-HPLC and HPTLC method were developed and validated for the simultaneous estimation of Teneligliptin hydrobromide hydrate and Glimepiride. RP-HPLC method was developed in reverse phase mode using acetonitrile and phosphate buffer (pH 3 adjusted with orthophosphoric acid) as mobile phase in the ratio of 65:35 (v/v) at a flow rate 1ml/min and. Quantitation was achieved with ultraviolet detection at 246nm and retention time was found to be 5.8 min and 9.41 min for Teneligliptin hydrobromide hydrate and Glimepiride respectively. The linearity was found to be in the range of 5 – 25 ng/ml and 0.25 – 1.25 ng/ml and recovery were found to be 98.80 and 99.68 % for Teneligliptin hydrobromide hydrate and Glimepiride respectively. The developed method is co-friendly and the peaks were more resolved when compared to the previous literatures with reduced flow rate. HPTLC method wasdeveloped on Merck TLC aluminium sheets of silica gel 60 F₂₂₂ using Toluene: Methanol: Triethylamine (1: 3: 1 v/v/v) as mobile phase. Quantitation was achieved with ultraviolet detection a 246 nm and Rf value was found to be 0.48 and 0.60 for Glimepiride and Teneligliptin hydrobromide hydrate respectively. The linearity was found to be in the range of 2000 – 20000 ng/spot and 100 – 1000 ng/spot and mean recovery was found to be 99.64 and 99.28 % of Glimepiride and Teneligliptin hydrobromide hydrate respectively. Both HPLC and HPTLC were found to be specific since there was no co-eluting peak with drug.