STABILITY-INDICATING RP-HPLC-UV METHOD FOR ESTIMATION OF IVABRADINE AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

Abstract

A simple, accurate, precise, and stability-indicating RP-HPLC-UV method was developed and validated for the simultaneous estimation of Ivabradine and Metoprolol Succinate in tablet dosage form. The chromatographic separation was achieved using an Agilent C18 (150 × 4.6 mm, 5 µm) column with a mobile phase consisting of Methanol:0.1% OPA (50:50, v/v) at a flow rate of 0.8 mL/min. The column temperature was maintained at 30°C with UV detection at 260.0 nm. The retention times for Ivabradine and Metoprolol were 2.210 min and 2.650 min, respectively. The method exhibited excellent precision with %RSD values of 0.4% and 0.6% for Ivabradine and Metoprolol, respectively. Recovery studies yielded 99.89% and 100.09% for Ivabradine and Metoprolol, respectively. Limits of detection (LOD) and quantification (LOQ) were 0.02 and 0.06 µg/mL for Ivabradine, and 0.24 and 0.74 µg/mL for Metoprolol, respectively. Linear regression equations were y = 33598x + 1032 for Ivabradine and y = 43436x + 2678 for Metoprolol with excellent correlation coefficients of 0.999. The developed method was validated according to ICH Q2(R2) guidelines and demonstrated to be simple, economical, stability-indicating, and suitable for routine quality control testing in pharmaceutical industries.