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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