HPLC analysis is the critical factors in the drug developing process, anditisimportant to ensure the reliability of the analytical procedure to obtain meaningful data. The International Conference on Harmonization (ICH) has recognized the importance of validation concerning analytical procedures, and issued the guideline on Validation of Analytical 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.

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