DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A precise, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Aclidinium Bromide and Formoterol Fumarate in pharmaceutical tablet dosage forms. The chromatographic analysis was performed using a Kromasil C18 column (250 × 4.6 mm, 5 μm), with a mobile phase comprising 0.1% perchloric acid buffer and acetonitrile in a ratio of 45:55 v/v. The flow rate was maintained at 1.0 mL/min, and detection was carried out at 230 nm. The retention times were approximately 2.1 minutes for Aclidinium Bromide and 2.7 minutes for Formoterol Fumarate. 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