Abstract
A sensitive and specific high-performance liquid chromatography method for the separation and determination of bedaquiline stereoisomers has been developed and validated. Ten different chiral columns were tested in a reversed-phase system. Excellent enantioseparation with a resolution of all isomers >2.0 was achieved for all stereoisomers on a Chiralcel OJ-3R column, using a mixture of 10 mM buffer of triethylamine/phosphoric acid pH 7.0 and acetonitrile (40 : 60; v/v). Bedaquiline (BDQ) stereoisomers were detected using UV-vis detector at a wavelength of 227 nm. The influence of mobile phase composition, namely buffer type, mobile phase pH and acetonitrile content in mobile phase, on retention and enantioseparation was studied. Validation of the developed method including linearity, limit of detection, limit of quantification, precision, accuracy and selectivity was performed according to the International Conference on Harmonisation guidelines. The advantages of the method are good enantioseparation and excellent selectivity; therefore, this is suitable for routine determination of chiral purity of (1R,2S)-BDQ in enantiopure active pharmaceutical ingredient.
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