Stability Indicating HPTLC Method for Bedaquiline Fumarate

Bedaquiline fumarate is an anti-TB treatment that was approved in 2012 and has a novel mechanism of action for fighting multidrug resistance (MDR). Bedaquiline fumarate, a diarylquinoline having significant bactericidal and sterilising activity, has been licenced by the US Food and Drug Administration,for the treatment of multidrug-resistant tuberculosis (MDR-TB).A simple, sensitive and stability indicating High Performance Thin Layer Chromatography method has been developed and validated for estimation of Bedaquiline fumarate as per ICH guidelines. Method was developed with silica gel 60 F254TLC plates using Acetonitrile: Ethyl acetate (7:3v/v) as mobile phase with densitometric detection at 229 nm. This system was found to give compact bands for Bedaquiline fumarate at (Rf 0.53 ±0.01). The linearity was observed in the range of200-1000 ng/band. Bedaquiline was exposed to different stress degradation conditions like hydrolysis at different pH, oxidation, photolytic and thermal degradation. The proposed method can used for routine quantitative determination of Bedaquiline.