ABOUT AUTHORS:
Rajani Pathuri*, M.Muthukumaran, B.Krishnamoorthy, Amreen Nishat
Montessori Siva Sivani Institute of Science & Technology-College of pharmacy
Mylavaram, Vijayawada, Andhrapradesh-521230
*rajani.prakash4@gmail.com
ABSTRACT
Analytical methods development and validation play important roles in the 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 compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.