Method Development and Validation for Estimation of Bedaquiline and in Tablet Dosage form by Hptlc and Rp-Hplc Study

Abstract

A diarylquinoline anti-mycobacterial drug, bedaquiline (BDQ), treats mycobacterial infections. It inhibits the proton pump by inhibiting mycobacterial Adenosine Triphosphate (ATP) synthase. ATP enzyme that is energy production requires Mycobacterium tuberculosis. The present study aimed to develop three analytical methods, i.e., High-performance thin-layer chromatography (HPTLC), HPLC, and UV, as BDQ estimation in tablet forms. HPTLC is employed in the first method, which uses ethanol-chloroform-toluene as the mobile phase (6:3.5:0.5). UV spectroscopy at 240nm was used to analyse BDQ at 100-300 micrograms per milliliter. RP-HPLC method based on the separation using a C18 column, Buffer (sodium acetate): Methyl alcohol (70:30) as mobile phase flowing at a rate of 1ml per min. The retention time was determined to be 5.4 minutes. At 240 nm, it could quantify the concentrations of 5-25 μg per ml at concentrations of 5-20 μg per ml. The third method involves the "UV-VISIBLE" spectrophotometric method. A range of BDQ concentrations is determined of 8-40μg/ml, respectively. These methods were checked to ICH guidelines, and as a result, a commercially available pharmaceutical formulation, with the findings of statistical comparison, was conducted between all three methods.