CHROMATOGRAPHY, Vol. 33 (2012), No. 2, pp. 65-73
Validation of analytical procedures by high-performance liquid chromatography for pharmaceutical analysis
Masato Kazusaki, Shinji Ueda, Naoto Takeuchi, Yasutaka Ohgami
Investigational Drug Quality Assurance, Technology Research & Development, Dainippon Sumitomo Pharma Co., Ltd.
3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan
HPLC analysis is the critical factors in the drug developing process, and it is important 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.
Keywords: validation, ICH, specificity, linearity, accuracy, precision.