抽象的

A Concise Review on Specific and Sensitive Analytical Method Development and Validation

Piyush Bachhav1*, Ruchita Bachhav2, Rushikesh Bachhav2, Ganesh Sonawane2, Kajal Pansare2, Dhananjay Patil2

Development and validation of analytical method 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 and LQQ in the routine and stability analysis all validation parameter is utilized and validation should be done as per ICH guidelines.