A Review on Specific and Sensitive Analytical Method Development and Validation

Authors: Piyush B*, Ruchita B, Rushikesh B, Ganesh S, Kajal P and Dhananjay P

DOI: 10.23880/oajpr-16000289

Volume 7, Issue 4

Abstract

The any pharmaceutical industry main goal of consistently and cost effective create goods the required characteristics and quality of product. The analytical method development and validation play an important role in the drug development and manufacturing of pharmaceuticals. Every year, a large number of molecules are introduced to the market therefore, it must be necessary to develop new analytical methods. After development processes it becomes necessary to validate the new analytical method. The analytical approach provides comprehensive information on the several validation parameters as per the ICH Q2 R1 guideline, including specificity, linearity and range, accuracy, precision, robustness, and LOD & LQQ in the routine and stability analysis all validation parameter is utilized and validation should be done as per ICH guidelines.

Keywords: Analytical Method; Chromatography; HPLC; Method Development; Validation

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