Stability Indicating UV Spectrophotometric Method For Linagliptin and Metformin in Pharmaceutical Dosage Form

摘要

Introduction: Linagliptin and metformin are newly introduced FDA drug combination for the treatment type 2 diabetic patients.This study reveals the development of three methods for the UV spectrophotometric simultaneous estimation of linagliptin and metformin in pharmaceutical dosage and forced degradation studies on four different stress conditions. Methods: Development of method was based upon simultaneous equation,absorbance ratio and absorbances correction method with a simple solvent system of distilled water. Absorption maxima was found to be 230.4nm, 294.4nm for metformin and linogliptin respectively without mutual interference. Isobestic point for both drugs was chosen at 250.4 nm. Stabilty studies were carried out on acid,alkaline,peroxide and thermal stress conditions. Conculsion: Degradation studies reveals that method capability on different stress condition. This method obeyed Beer’s law in the concentration range of 2-14 μg /ml for metformin and 10-40 μg /ml for linogliptin. The results of the analysis has been validated statistically. Method proven to be rapid,precise and cost effective for the routine analysis in pharmaceutical dosage form. Forced degradation outcomes can be used for the development of stable formulation and helps in the planning of proper storage requirement.