¹Department of Pharmaceutics, Faculty of Pharmacy, Parul University, Vadodara 391760 Gujarat, India
²Department of Pharmaceutics, Faculty of Pharmacy, Sardar Patel College of Pharmacy, Anand 388315 Gujarat, India The FDA-approved diaryl-quinoline anti-mycobacterial drug called bedaquiline fumarate is used to treat pulmonary multi drug resistant tuberculosis. It inhibits proton pump of mycobacterial ATP synthase, an enzyme necessary for production of energy in mycobacterium tuberculosis bacteria. According to ICH Q2(R1) guideline, this research presents simple, rapid, reproducible and cost-effective UV spectrophotometric method for estimation of bedaquiline fumarate in bulk and pharmaceutical formulations. Phosphate buffer pH 7.4 was selected as solvent for the measurement of λmax at 200nm-400nm wavelength range and further investigated for Linearity, Accuracy, Ruggedness, Intraday and Interday Precision, Limit of quantification (LOQ) and limit of detection (LOD). The λmax in phosphate buffer pH 7.4 was found to be 285.88nm and the method was discovered to be linear over the range of 10µg/ml-70µg/ml with R2 value of 0.9974. After the concentration spikes of 80%, 100%, and 120% in the accuracy study, the mean %recovery was determined to be 101.18%, 100.95%, and 100.60%, respectively, and %RSD was less than 2.0%. For the 10µg/ml sample solution, there was no appreciable difference in the data from two independent analysts. The suggested method was therefore thought to be reproducible and rugged. Intraday and interday precision were demonstrated with less than 2.0%RSD. The Limit of quantification (LOQ) was determined to be 3.884µg/ml and the limit of detection (LOD) to be 1.282µg/ml. The assay of bedaquiline fumarate didn’t interfere by the excipients used in the formulation of inhaled dry powder of bedaquiline fumarate loaded nano structured lipid carrier (NLC) capsules 50mg. This method is useful for routine analysis of bedaquiline fumarate in bulk and pharmaceutical formulations. Keywords : Bedaquiline Fumarate; UV Spectrophotometry; bedaquiline fumarate loaded NLC; DPI; ICH Q2(R1) Guideline