ISSN : 2663-2187

An improved validated RP-HPLC method for simultaneous estimation of Metformin Hydrochloride, Sitagliptin phosphate and Dapagliflozin from finish dosage form

Main Article Content

Ajay D Patil, Vikas D Patil, Jayesh Patil, N. N. Jha, Ramesh Yamgar
» doi: 10.48047/AFJBS.6.14.2024.9162-9190

Abstract

A simple and precise reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous determination of Metformin (MET) hydrochloride, Sitagliptin phosphate (SITA) and Dapagliflozin (DAPA) in bulk and pharmaceutical dosage form. Chromatography was carried out on Zorobax Eclipse plus Phenyl Hexyl C18 (250 mm × 4.6 mm, 5 µ particle size) column containing mobile phase of Buffer: Methanol: Acetonitrile in the ratio of 40:35:25% v/v. (1ml of Triethylamine is added and pH is adjusted to 3.7 with 0.1% Orthophosphoric acid) at a flow rate of 1.0 ml/minute. The analyte was monitored using Photo Diode Array Detector (PDA) at 267 nm. The retention time was found to be 2.71 minutes, 3.65 minutes and 8.99 minutes for MET hydrochloride, Sitagliptin phosphate and Dapagliflozin respectively. Validation parameters specificity, linearity, accuracy, precision and robustness have been observed to be desirable over the concentration ranges of 500 µg/ml, 100 µg/ml & 10 µg/ml for Metformin (MET) hydrochloride, Sitagliptin phosphate (SITA) and Dapagliflozin (DAPA) respectively. The method developed has been statistically validated according to ICH guidelines.

Article Details