ANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW

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Published May 21, 2019

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Mr. Mahesh S Patil
Department of Pharmaceutical Quality Assurance. R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur.
Dr. Rvindra. R. Patil
Department of Pharmaceutical Quality Assurance. R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur.
Dr. Shailesh. S. Chalikwar
Department of Pharmaceutical Quality Assurance. R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur.
Dr. Sanjay J Surana
Department of Pharmaceutical Quality Assurance. R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur.
Dr. Sandip D Firke
Department of Pharmaceutical Quality Assurance. R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur.

Abstract

The development of sound Analytical method is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product.The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
Keywords: Analytical method validation, Pharmaceutical analysis, Specificity, Precision, Accuracy.

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How to Cite
Patil, M. M. S., Patil, D. R. R., Chalikwar, D. S. S., Surana, D. S. J., & Firke, D. S. D. (2019). ANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW. International Journal of Pharmaceutical and Biological Science Archive, 7(3). Retrieved from http://ijpba.in/index.php/ijpba/article/view/126
Issue
Vol 7 No 3 (2019)
Section
Research Article
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