Abstract

HIGH -PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE METHOD DEVELOPMENT OF URSOLIC ACID AND MOMETASON FUROATE: DEVELOPMENT AND VALIDATION

Neetu Yadav*, Rahul Dubey

Abstract

The present work describes the development and validation of a high-performance liquid chromatography (HPLC) method for the quantitative estimation of Ursolic Acid and Mometasone Furoate in pharmaceutical dosage forms. Chromatographic optimization was performed using a C18 column and different mobile-phase compositions, flow rates, wavelengths, and column temperatures. The optimized chromatographic condition used methanol:water (60:40, v/v), a flow rate of 1.0 mL/min, detection at 296 nm, column temperature of 40 C, and a total run time of 5 min. The method was evaluated for linearity, system suitability, accuracy, precision, robustness, LOD, LOQ, and applicability to marketed formulations. Calibration data showed proportional increases in peak area across 10-60 ug/mL for Mometasone Furoate and 5-30 ug/mL for Ursolic Acid. System suitability data showed acceptable repeatability for retention time, theoretical plates, tailing factor, and resolution. Recovery values were close to 100% for both analytes, and intra- and interday %RSD values were below 1% in the supplied data. The method was further applied to Cystone and Yam Balance marketed preparations, where assay values were close to label claim. These findings indicate that the developed method is suitable for routine analysis, subject to verification of the noted source-data inconsistencies before journal submission.

Keywords: HPLC; method development; analytical validation; Ursolic Acid; Mometasone Furoate; pharmaceutical dosage form; accuracy; precision; robustness.