Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD USING AREA UNDER CURVE FOR THE SIMULTANEOUS ESTIMATION OF LOBEGLITAZONE SULPHATE AND DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE IN A SYNTHETIC MIXTURE

Khan Sheherbanu* and Mahida Rajvi

ABSTRACT

A simple, rapid, and cost-effective UV spectroscopic method has been developed and validated for the simultaneous estimation of Lobeglitazone Sulphate and Dapagliflozin Propanediol Monohydrate in a synthetic mixture using the Area Under the Curve (AUC) method. The method was optimized with Lobeglitazone Sulphate measured in the wavelength range 233-243 nm (0.5-2.5 µg/ml) and Dapagliflozin measured in the range 220-230 nm (10-50 µg/ml). Methanol was selected as the solvent after solubility studies. The method was validated for linearity, precision, accuracy, LOD (Limit of Detection), and LOQ (Limit of Quantitation). The linearity of the method was confirmed with a correlation coefficient for both drugs, while precision was assessed through repeatability, intraday, and interday studies. The LOD and LOQ were calculated to determine the sensitivity of the method. Accuracy was evaluated by recovery studies, demonstrating the reliability of the method. The developed method provides a reliable tool for the routine analysis of these drugs in combination dosage forms.

Keywords: Lobeglitazone Sulphate, Dapagliflozin Propannediol Monohydrate, Area Under Curve, Validation.