Abstract

PERSPECTIVES ON ANALYTICAL METHOD VALIDATIONSTRATEGIES AND IMPORTANCE IN PHARMACEUTICAL RESEARCH

M. Sudheeshna, M. Malarvannan*, K. Vinod Kumar and B. Kranthi Kumar

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Abstract

Providing proof that a certain technique, method, equipment, material, activity, or system operates as intended under a specific environment and also offers the necessary degree of accuracy, precision, sensitivity, ruggedness, and other properties is the process of validating. A process, element, substance, activity, or system can be validated if it can show that it performs as intended under a certain set of circumstances. When used in reference to an analytical technique, it means that a method consistently produces the desired results whether it is used by the same individuals or other individuals, in the same or various laboratories, with different chemicals or equipment, etc. One of the most crucial tasks that must be completed during the phases of drug discovery, development, and, eventually, approval for sale on the market, is the design of analytical procedures. From formulation research on up to commercial batch manufacturing, designing, optimising, and verifying the pharma product's process is crucial. As a result, the development and manufacturing phases are included in this time frame. The development of drug product methods seeks to offer practical methods for assessing specificity, selectivity, the limit of quantitation, the limit of detection, accuracy, linearity, range, and precision, as well as recovery and solution stability. This article examines the methodology for validating analytical approaches and their significance.

Keywords: Validation, Analytical Methods, HPLC, ICH, USP, BP.