A New Stability Indicating Hplc Method For Simultaneous Determination Of Related Substances In Metformin Hydrochloride, Empagliflozin And Linagliptin In Bulk Material And Pharmaceutical Formulation

Abstract

The objective of the study was to develop a simple, specific and stability-indicating HPLC method for the simultaneous determination of Metformin hydrochloride, Empagliflozin and Linagliptin and its related substances in pharmaceutical formulation. Separation of Metformin hydrochloride, Empagliflozin and Linagliptin from its major degradant impurities was achieved on aAccucoreC18 column (150 × 4.6 mm, 2.6 μm) Thermo Scientific with a Buffer solution pH 1.70 and Acetonitrile with Gradient Program at a flow rate of 0.8 mL min-1. The analytes were detected at 230 nm. Different chromatographic parameters were carefully optimized. The relative response factors for DEG-1, N-Formyl Lina of Linagliptin, Metformine Impurity B of Metformin hydrochloride, and Hydroxy Empagliflozin of Empagliflozin in combined pharmaceutical formulation were determined. The method has been validated with respect to solution stability, system suitability, LOD, LOQ, linearity, accuracy, precision, specificity and robustness. The validation criteria were met in all cases. The developed method was successfully used for the detection and quantification of known impurities and degradants in the drug substance of Metformin hydrochloride, Empagliflozin and Linagliptin during routine analysis and also for stability studies in view of its capability to separate degradation products.