Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION: A REVIEW

M. Mohan Varma, Ashok Thulluru, K. T. Sunil Kumar, G. Sai Kumar and *K. Pavani

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Abstract

High performance liquid chromatography the most precise techniques commonly used for the qualitative and quantitative study of drug substance. Drug research, drug production, and pharmaceutical manufacturing all depend on the development and evaluation of analytical methods. It involves evaluating a drug substance's purity and toxicity. To refine the methods in the study of system production in HPLC, a variety of chromatographic parameters were evaluated. We create an effective mobile phase, column, column temperature, wavelength, and gradient. Force degradation tests aid in the discovery and validation of stability-indicating experiments, as well as the identification of drug product and drug substance degradation pathways. The aim of validating an empirical technique is to show that it is suitable for intended purpose. In accordance with ICH guidelines, the parameters accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range, ruggedness, and robustness are specified here.

Keywords: HPLC, Degradation, Impurities, Method developments, Validations.