Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BEDAQUILINE: REVIEW

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

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Abstract

Analytical method development and Validation are the continuous and inter-dependent task associated with the research & development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product-specific acceptance criteria and stability of results. Validations determine that the analytical procedure is suitable for its intended purpose. Literature survey reveals that the analytical methods based on UV spectrometry, RP-HPLC and LCMS for the determination of Bedaquiline personally and in combination with different drugs. The parameters were validated according to ICH guideline in terms of accuracy, precision, robustness, and other components of analytical validation. The developed methods are simple, sensitive and reproducible and can be used for the analysis of Bedaquiline in bulk and Tablet dosage form.

Keywords: Bedaquiline, Literature Survey, UV, HPLC, LC\MS, Validation, ICH Guidelines.