Development of a Stability-Indicating Rp-Hplc Method for the Simultaneous Estimation of Metformin, Teneligliptin, And Dapagliflozin in Bulk and Combined Dosage Form

Abstract

Introduction: The increasing worldwide prevalence of Type 2 Diabetes Mellitus makes it necessary to provide trustworthy analytical techniques for the simultaneous estimation and stability evaluation of formulations containing combinations of antidiabetic drugs.

Objectives: The objective of this study is to develop and validate a quick, sensitive and stability-indicating Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Metformin, Teneligliptin and Dapagliflozin in bulk and tablet dosage forms

Methods: Chromatographic separation was achieved using a C18 column with a mobile phase consisting of acetonitrile and 0.1% orthophosphoric acid in a 40:60 ratio. The detection wavelength was set at 220 nm. System suitability parameters including theoretical plates, tailing factor and resolution were evaluated. The method was validated for accuracy, precision and robustness. Forced degradation studies were conducted under acidic, basic, oxidative, photolytic and thermal stress conditions to assess the stability-indicating capability of the method.

Results: The developed method showed excellent linearity within the specified concentration ranges, with correlation coefficients greater than 0.999. System suitability parameters met the acceptable criteria. Validation results confirmed that the method is accurate, precise and robust. Forced degradation studies demonstrated that degradation products did not interfere with the analyte peaks, confirming the stability-indicating nature of the method.

Conclusions: The developed RP-HPLC method provides an efficient and reliable tool for routine quality control and stability analysis of combination antidiabetic formulations. It ensures safe therapeutic efficacy, regulatory compliance and formulation integrity, making it suitable for pharmaceutical industries and research laboratories involved in multi-drug therapy quality assessment due to its high reproducibility, sensitivity and selectivity.