VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF BEDAQUILINE IN BULK AND TABLET DOSAGE FORM

Chethan Gowda S.*, Jose Gnana Babu C. and Sowmya H. G.

ABSTRACT

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Bedaquiline in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 226nm in Methanol solution and Area under Curve [AUC] in absorption spectra were measured between the wavelength range 221 to 231nm which obeys Beer’s law in the concentration range of 0.5-2.5 μg/ml. The linearity study was carried out and regression coefficient was found to be 0.9999 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 96.14-99.15. The LOD and LOQ were found to be 0.0197 and 0.0598μg/ml. The percentage relative standard deviation was found to be less than 2. According to ICH guidelines the method have been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine quantitation of Bedaquiline in bulk and pharmaceutical dosage form.

Keywords: Bedaquiline, Area under curve spectroscopy, validation, pharmaceutical formulations.