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Abstract

A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VALGANCICLOVIR HYDROCHLORIDE

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

ABSTRACT

Many theories have proposed to explain the Analytical method development and validation of Valganciclovir hydrochloride. Although the literature survey covers a wide variety of such theories, so the development of sound analytical method is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. So the objective of this paper is to review the method development, optimize and validation of the method for the Valganciclovir hydrochloride from the development stage of the formulation to commercial batch of the product. So the method development helps in establishment of product specific acceptance criteria and stability of results. Literature survey reveals that the analytical methods based on UV spectrometry, HPLC & HPTLC for the determination of Valganciclovir hydrochloride. The above methods are validated according to ICH guidelines in terms of accuracy, precision, robustness, and other aspects of analytical validation. Although the literature presents these method developments in a variety of contexts, this review article primarily focus on providing simple, sensitive and reproducible Analytical method for the development and validation of Valganciclovir hydrochloride.

Keywords: Valganciclovir hydrochloride, Method Development, Validation, Literature Survey, ICH Guidelines.


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