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Abstract

A REVIEW ON DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD

Tejes Jatar*, R.N.Kachave, Chaudhari S. R.

ABSTRACT

Analytical method development and validation play important role in discovery , development and manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compound dosage form which allow simplified procedure to be employed to verify that an analysis procedure , accurately and consistently will deliver a reliable measurement of an active ingradient in a compound preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, precision, range, and robustness.

Keywords: Validation , Method Development, HPLC.


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