RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF BETAMETHASONE AND OFLOXACIN IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A precise, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Betamethasone and Ofloxacin in pharmaceutical tablet dosage forms. The chromatographic analysis was performed using a Phenomenex C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase comprising 0.01 N potassium dihydrogen phosphate (KH₂PO₄) buffer at pH 4, acetonitrile, and methanol in the ratio of 60:30:10 (v/v/v). The flow rate was maintained at 1.0 mL/min, and detection was carried out at 265 nm. Retention time of Betamethasone and Ofloxacin were found to be 2.1min and 4.1min. The method was validated according to ICH Q2(R1) guidelines for parameters including linearity, precision, accuracy, sensitivity, robustness, and system suitability. The developed method proved to be simple, economical, and suitable for routine quality control analysis in pharmaceutical industries.