Abstract
REVIEW ON: AN ANALYSIS ON ANALYTICAL METHOD VALIDATION AND ITS REGULATORY VIEWPOINTS

Sanni Gangwar*, Manoj Kumar, Pratiush Saxena and Dr. Atul Kumar Gangwar

ABSTRACT

Analytical methods play vital role in the process of identification, separation and then quantification of chemical components in natural materials or synthetic ingredients based on their chemistry. The main drive of the analytical method validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety or drug product. The analytical method validation is essential for analytical method validation and tested for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness. In summary, analytical method validation confirms that an accurate, precise and reliable potency measurement of a pharmaceutical preparation can be performed. The review article was to check the validation of the procedure employed for the medication from the starting of the formulation to the completed commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associate samples, it is necessary that the outcomes are reliable.

Keywords: AMD, AMV, API and drug product.


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