Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION: AN OVERVIEW

Sanjay B. Vasave*, Uday A. Deokate and Annapurna Gupta

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Abstract

For the discovery, creation, and production of pharmaceuticals, analytical method development and validation are essential. Various new medications enter the market each year; therefore, it is necessary to create updated analysis techniques for such medications. The following development. The primary objective of this review article was to evaluate the design and validation of the process used for the medication from the beginning of formulation to the final commercial batch of product. It is essential that the results are acceptable when an analytical technique is used to produce assessments about the quality of samples related to medicine. The requirements of good manufacturing practise (GMP) standards are adhered to in the pharmaceutical industry's validation policy, which is documented for how to do validation. Validation is crucial to the efficient operation of pharmaceutical companies. Validation was done at every level, from the raw materials to the finished product. The method was appropriately established, and validation parameters are described in terms of accuracy, specificity, and precision as well as limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing with the use of specific pharmaceuticals as examples. All validation parameters are used in the routine and stability analysis.

Keywords: UV Visible Spectroscopy, Method development, Validation, Limit of quantitation, Limit of detection, Accuracy, Linearity, Robustness, Ruggedness.