Analytical Method Development and Validation for Estimation of Bedaquiline (BDQ) Using RP-HPLC

The United States Food and Drug Administration (USFDA) approved bedaquiline (BDQ) in 2012 for the treatment of drug-resistant tuberculosis, which has become a serious global issue. For the measurement of bedaquiline in bulk medication, a reversed-phase high performance liquid chromatography (RP-HPLC) approach was devised and validated. The separation was obtained using a 10mM Ammonium acetate: methanol in the ratio 15:85 v/v (pH adjusted to 4.5 with OPA) as mobile phase at a flow rate of 1.0 ml/min on a Thermo C18 analytical column (250mm4.6 mm i.d.,5.0µ). A UV detector with a 232mm focal length was used for detection. The entire chromatographic analysis time per sample was around 5.0 minutes, with emtricitabine eluting at roughly 3.225minutes retention time. The accuracy, precision, specificity, linearity, and sensitivity of the approach were all tested. Validation studies have shown that this HPLC approach is simple, specific, quick, dependable, and repeatable. The standard curve was linear over the concentration range of 5-25μg/ml with r2 close to one (0.999). Bedaquiline had a limit of detection (LOD) of 0.3525μg/ml and a limit of quantitation (LOQ) of 0.95 25μg/ml, respectively. The suggested method's high recovery and low relative standard deviation show its usefulness for determining bedaquiline in pharmaceutical formulations.