Analytical Method Development and Validation: Quantitative Estimation for Assay of Revefenacin in Pharmaceutical Dosage form by RP-HPLC method

Revefenacin is a medication for the treatment of chronic obstructive pulmonary disease (COPD). A simple, accurate and precise reversed-phase high-performance-liquid-chromatography (RP-HPLC) method was developed and validated for Revefenacin in bulk and pharmaceutical dosage forms. The method was optimized by selecting chromatographic conditions of 30:70 v/v, 0.2% Perchloric acid solution: Acetonitrile used as a mobile-phase, Inertsil® column ODS-3V (4.6mm* 25 cm, 5μm), injection volume 20μL, flow-rate 1.0ml/min at an ambient temperature of column oven (25°C), auto-sampler temperature 15°C and λmax 242nm. A different column of C18-Kinetex F-5 (4.6mm* 25 cm, 5μm) was also examined, reporting no significant divergence in the results obtained. The method was further validated, giving good precision (%RSD/CV<1.0) and acceptable linearity (r≥0.999) on both columns. The pharmaceutical revefenacin drug offers a high recovery rate of 99.77%. The proposed method is observed as simple, rapid and economical and can be employed for routine analysis in quality control laboratories.