Development And Validation Of Analytical Method For Simultaneous Estimation Of Empagliflozin And Metformin By Rp-Hplc

Abstract

The objective of this study was to develop and validate a reliable, efficient, and robust RP-HPLC method for the simultaneous estimation of Empagliflozin and Metformin in pharmaceutical dosage forms. A high-performance liquid chromatography (HPLC) method was developed using a mobile phase consisting of methanol and acetonitrile (75:25 v/v), with an X-Bridge C18 column (4.6 × 150 mm, 5.0 µm) for the separation of both drugs. The chromatographic separation was performed at a flow rate of 1 mL/min and the detection was carried out at 260 nm. The column temperature was maintained at 35ºC, and the injection volume was 10 µL. The total run time was 14 minutes, allowing for efficient separation of Empagliflozin and Metformin within a short analysis time. The method was validated in accordance with ICH guidelines, covering parameters such as accuracy, precision, linearity, specificity, and robustness. The results demonstrated that the method is accurate, precise, and reproducible, with good resolution between the two drugs. The method exhibited excellent linearity with correlation coefficients greater than 0.999 for both Empagliflozin and Metformin. The limit of detection (LOD) and limit of quantification (LOQ) were found to be suitable for routine pharmaceutical analysis. This validated RP-HPLC method can be effectively employed for the quality control of Empagliflozin and Metformin combination products in the pharmaceutical industry, ensuring the integrity and safety of the drug formulation.