Use Of Rp-Hplc For The Analytical Method Development Of Anti-Tubercular Drug- Bedaquiline

Abstract

A rapid sensitive and accurate method for the quantitative and qualitative estimation of bedaquiline was developed using the reverse
phase HPLC (RP HPLC) method using acetonitrile and 0.1% trifluoroacetic acid as mobile phase. The system’s suitability was
established. The method was validated as per ICH guidelines. The system suitability was established with a good resolution of peak and retention time of 2.27min. The linearity was established at 242nm in the range of 30-180µg/ml, with a correlation corrfiecint of 0.9999.
The limit of detection and the limit of quantification was found to be 3µg/ml and 12µg/ml respectively. The accuracy and precision of
the process were found to be within the limit of acceptance calculated through relative standard deviation(RSD). The robustness of the
process was established with a deliberate change in the injection flow rate, the content of the organic phase and the wavelength. The
chromatographic method was found to be specific for the determination of the analyte in a photodegradation study of the known
concentration of the sample. Hence it can be concluded that the overall process is simple, rapid, accurate and robust enough for the
routine analysis of Bedaquiline in pharmaceutical formulation.