A Review on Analytical method Development and Validation
Abstract
Analytical method development, validation, and transfer are essential elements of any pharmaceutical development program. Effective method development confirms that laboratory resources are optimized, while methods meet the purposes required at each stage of drug development. High performance liquid chromatography is most accurate methods extensively used for the qualitative and quantitative analysis of drug product. Analytical method development and validation play vital role in the drug discovery, Drug development and manufacture of pharmaceuticals. It includes detection of the purity and toxicity of a drug substance. A number of chromatographic parameters have been evaluated in order to optimize the methods in the analysis of method development in HPLC. Ansuitable mobile phase, column, column temperature, wavelength, and gradient are developed.
Keywords: Analytical method validation, ICH, HPLC, Method Validation, Regulatory Requirements.
DOI
https://doi.org/10.22270/jddt.v9i3-s.2957References
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