화학공학소재연구정보센터
Process Control and Quality, Vol.10, No.1, 59-73, 1997
Regression and calibration for analytical separation techniques. Part I: Design considerations
Proper use of calibration methods in separation science is an indispensable prerequisite for accurate and precise quantitative analytical methods. This paper outlines an economic and straightforward strategy to calibration method development. Special emphasis is put on situations related to separation techniques in drug quality control. Taking precautions against potential problems while validating the analytical method, economic calibration method development includes a number of considerations and experiments prior to the first calibration. These prior steps include the specification of the calibration range, estimation of the error due to sample preparation, paying regard to matrix interferences, deciding upon the use of an internal standard and examination of the robustness and precision of the method under development. Thoroughly considering all these issues accelerates method development, supports evaluation of the gathered data, and makes method validation easier. Experimental designs for calibrations are suggested for method development (24 measurements), routine and re-calibrations (6 measurements).