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Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF BEDAQUILINE IN BULK AND PHARMACEUTICAL FORMULATIONS

B. S. Pooja* and Dr. A Sathish Kumar Shetty

ABSTRACT

The aim of present work were to develop an simple, accurate and precise zero order derivative method and Area under curve (AUC) method for the estimation of Bedaquiline and validation according to ICH Q2(R1) guideline. The absorbance maxima was determined at 285nm using Acetonitrile as solvent. The area selected for the estimation of Bedaquiline was between 275 to 295nm. The method represented the correlation coefficient (R2 = 0.999 for Zero order & R2 = 0.999 for First order Derivative methods) at concentration range 15- 75μg/ml. The methods were validated for the parameters such as linearity, accuracy, precision, and limit of quantification & limit of detection as per ICH guidelines. The proposed methods were thus found suitable for estimation of Bedaquiline in bulk and tablet formulations without any interference of the excipients.

Keywords: Bedaquiline, Zero order, AUC, Validation.


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