ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DEXAMETHASONE: REVIEW

Akshatha A.*, Sowmya H. G. and Jose Gnana Babu C.

ABSTRACT

Analytical method development and validation are the continuous and interdependent task associated with the research and 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 demonstrate that the analytical procedure is suitable for its intended purpose. Literature survey reveals that the analytical methods based on UV spectrometry, RP-HPLC & HPTLC for the determination of dexamethasone individually and in combination with other drugs. The methods were validated according to ICH guideline in terms of accuracy, precision, robustness, and other aspects of analytical validation. The developed methods are simple, sensitive and reproducible and can be used for the routine analysis of dexamethasone in bulk and Tablet dosage form.

Keywords: Dexamethasone, Literature Survey, Method Development, Validation, ICH Guidelines.