RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF CILNIDIPINE AND NEBIVOLOL IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Cilnidipine and Nebivolol in tablet dosage form. Chromatographic separation was achieved using a Hypersil BDS C18 column (150 mm x 4.6 mm, 5 μm) with a mobile phase consisting of acetate buffer and acetonitrile in the ratio of 30:70 v/v. The flow rate was maintained at 1.0 mL/min, and the detection wavelength was set at 256 nm. The retention times for Cilnidipine and Nebivolol were found to be 2.3 and 2.8 minutes, respectively. The method showed good linearity in the range of 5–30 μg/mL for Cilnidipine and 2.5–15 μg/mL for Nebivolol, with correlation coefficients of 0.999. The method was validated as per ICH Q2(R1) guidelines for precision, accuracy, linearity, robustness, LOD, and LOQ. The proposed method can be successfully applied for routine quality control of the cited drugs in pharmaceutical formulations.