SIMULTANEOUS METHOD FOR THE ESTIMATION OF BEDAQUILINE AND DELAMANID IN HUMAN PLASMA USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

Objective: A specific, simple and sensitive high-performance liquid chromatographic method for the estimation of Bedaquiline (BDQ) and Delamanid (DLM) in human plasma was developed. Methods: The method involved deproteinization and further extracted the analyte using Solid Phase Extraction (SPE) cartridge and analysed using C18 column with the wavelength set at 231 nm. The isocratic mobile phase consisted of 10 mmol ammonium acetate buffer containing 0.25% acetic acid and 0.02% trifluoroacetic acid and acetonitrile in the ratio of 20:80(v/v). The validation parameters were evaluated. The method was applied to estimate plasma BDQ and DLM collected from five MDR-TB patients. Results: Well resolved peaks of BDQ and DLM at retention times of 5.4 and 2.6 min were obtained respectively. The calibration curve was linear over a range of 0.01–10.0 µg/ml for both BDQ and DLM. The intra-and inter-day relative standard deviations for standards were below 10%. The recoveries for BDQ ranged from 101% to 107% and 98% to 107 % for DLM respectively. Conclusion: A specific and sensitive method for simultaneous determination of BDQ and DLM in plasma using high-performance liquid chromatography was developed. This method can be used in clinical studies to evaluate drug exposure.