Development and Analytical Method Validation for Simultaneous Estimation of Evoglptin Tartrate and Metformin Hydrochloride in Combine Dosage Form

Abstract

Metformin hydrochloride is a diabetes medication that is used orally. Evogliptin tartrate is a dipeptidyl peptidase-4 (DPP-4) inhibitor which has been authorized as a new and powerful treatment in the process of reducing glucagon-like peptide 1 (GLP-1) deficiency while increasing insulin production and decreasing glucagon levels. The current study created a simple, highly exact, and rapid reverse phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of metformin hydrochloride and evogliptin tartrate in their combined dose form. High-performance liquid chromatography (HPLC), was performed on a phenomenex Luna C18 column with a mobile phase of water 25: acetonitrile 75 (25:75) at a 1.2 mL/min flow rate, with detection at 210 and 230 nm for metformin hydrochloride.and evogliptin tartrate. The validation method comprised of several variables like linearity, accuracy, selectivity, precision, robustness and specificity. The retention time of the metformin hydrochloride and evogliptin tartrate was 2.009 and 2.956 minutes, respectively. The method procedure linear responses of metformin hydrochloride and evogliptin tartrate was found to be 1 and 0.997, respectively. The percent relative standard deviation was less than 2% for intraday variation/precision, interday variation/precision, intermediate ruggedness, and robustness. The projected technique produced excellent results for many dependent variables. The projected method showed outstanding results with respect to different dependent and independent variables like limit of detection and limit of quantitation, suitability of system, linearity range etc., linearity, accuracy, precision, and specificity. The results were within the acceptance criteria given in ICH guideline.