SIMULTANEOUS ESTIMATION OF DELAMANID AND BEDAQUILINE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Abstract

A simple, accurate, precise, and economical RP-HPLC method was developed and validated for the simultaneous estimation of Delamanid and Bedaquiline in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved using a Kromasil C18 column (150 × 4.6 mm, 5.0 µm) with a mobile phase consisting of 0.01 N ammonium acetate buffer and acetonitrile in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1.0 mL/min, and the column temperature was maintained at 30°C. The ammonium acetate buffer was prepared by adding 0.1% acetic acid and adjusting the pH to 4.0. The optimized detection wavelength was 220 nm. The retention times of Delamanid and Bedaquiline were found to be 2.249 and 2.970 min, respectively. The percentage RSD for Delamanid and Bedaquiline was found to be 1.4% and 0.5%, respectively, indicating good precision. The percentage recovery was found to be 99.69% for Delamanid and 99.90% for Bedaquiline. The LOD and LOQ values obtained from the regression equations were 0.10 and 0.30 for Delamanid and 0.25 and 0.74 for Bedaquiline, respectively. The assay results were found to be 99.52% for Delamanid and 99.95% for Bedaquiline. The regression equations were y = 19629x + 3362.1 for Delamanid and y = 23316x + 9810.4 for Bedaquiline. The developed method provided short retention times and reduced total analysis time, making it simple, rapid, economical, and suitable for routine quality control analysis of Delamanid and Bedaquiline in pharmaceutical industries.