ANALYTICAL METHOD VALIDATION: A BRIEF REVIEW

Method development is a broad term. In both quantitative and qualitative analysis developing a new method either for estimation of quantity of substance or to check the presence of the required component is a necessitate step. Validation means to establish the characteristics parameters of the method. It also helps by revealing the limitations and their extent of the method. Both terms are essential to create and then establish for any drug component so that it can be used in any pharmaceutical industry for its benefitValidation is an applied approach to verify that a method is suitable to function as a quality control tool. The objective of any analytical measurement is to obtain consistent, reliable and accurate data. Validated analytical methods play a major role in achieving this goal. An analytical method consists of the techniques, method, procedure and protocol. Analytical method validation includes the determination of accuracy, precision, LOD, LOQ, linearity and range. The results from method validation can be used to moderator the quality, reliability and consistency of analytical results, which is an integral part of any good analytical practice. Validation of analytical methods is also required by most regulations and quality standards that impact laboratories. The main objective of this review article is to guide the young researchers to improve the quality of analytical method development and validation process. Generally, the guidelines are followed as laid by ICH and USP which are followed worldwide Keywords: Validation; Accuracy; Precision; Case study; Validation report