Research Article | Open Access
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS QUANTIFICATION OF DAPAGLIFLOZIN, SAXAGLIPTIN, AND METFORMIN IN COMBINED FORMULATIONS
Anil Kumar G, Raghunath Gampa, Rajveer Chiliveri
Pages: 1445-1450
Abstract
The simultaneous quantification of Dapagliflozin, Saxagliptin, and Metformin in combined pharmaceutical formulations is essential for ensuring quality control, regulatory compliance, and therapeutic efficacy. This study focuses on the development and validation of a novel analytical method for the precise and accurate estimation of these antidiabetic drugs in a synthetic mixture.
A high-performance liquid chromatography (HPLC) method was optimized using a reverse-phase column, a suitable mobile phase, and an appropriate detection wavelength to achieve effective separation and quantification. The method was validated as per ICH guidelines, assessing key parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ).
The results confirmed that the developed method provided high sensitivity, reproducibility, and accuracy, making it suitable for routine analysis in pharmaceutical quality control and stability studies. The study concludes that this validated analytical method is a reliable, cost-effective, and efficient approach for the simultaneous estimation of Dapagliflozin, Saxagliptin, and Metformin, ensuring compliance with pharmaceutical standards.
Keywords
RP-HPLC, UV Spectroscopy, Validation Parameters, Method Development and Validation.