Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF URSODIOL: REVIEW

Karthik N. R.*, Sowmya H. G. and Jose Gnana Babu C.

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 HPTLC for the determination of Ursodiol 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 Ursodiol in bulk and Tablet dosage form.

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