Validation of Analytical Methods : A Simple Model for HPLC Assay Methods

HSING-CHU HSU AND *CHUN-SHENG CHIEN

Department of Pharmaceutics, Chia Nan Junior College of Pharmacy, Tainan-hsien, Taiwan, R.O.C.
*National Laboratories of Foods and Drugs, Department of Health, Executive Yuan, R.O.C.

ABSTRACT

   A simple model for the validation of HPLC analytical methods, to be carried out in a typical laboratory within the constraints of time and cost, is described by reviewing currently available validation methods. The statistical techniques employed in assessing the accuracy, precision, selectivity, reproducibility, sensitivity and validity of a non-official assay method in comparison with the compendial method are reviewed and demonstrated.

Key words : Validation, HPLC, analytical model.