REVIEW ON METHOD DEVELOPMENT AND VALIDATION
Keywords:
Qualitative, Quantitative, Force degradation, Method development, Stability, ICHAbstract
High performance liquid chromatography is most accurate methods widely used for the qualitative and quantitative analysis of drug product. Analytical method development and validation play important roles in the Drug discovery, Drug development and Manufacture of pharmaceuticals. It involves 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. An appropr- iate mobile phase, column, column tempe- rature, wavelength and gradient are develop- ped. Force degradation studies are helpful in development and validation of stability-indicating studies, determination of degrad- ation pathways of drug substances and drug products. Validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. The parameters described here are according to ICH guidelines and include accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range, ruggedness and robustness. The objective of this paper is to review the method development, optimize method parameters and validation of method for drug product from developm- ental stage of formulation to commercial batch of product.
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