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

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