Validation of analytical procedures by high−performance liquid chromatography for pharmaceutical analysis

Abstract

HPLC analysis is the critical factors in the drug developing process, an di ti s important to ensure the reliability of the analytical procedure to obtain meaningful data. The International Conference on Harmonizatio n (ICH) has recognized the importance of validation concerning ana- lytical procedures, and issued the guideline on Validation of Analyti cal Procedures (Q2) as a frame work for the validation study. This report complements the ICH guideline Q2, and provides practicable means for validation study focusing on the analyses by HPLC