Vol. 2, Issue 6 (2017)
Analytical Method development, Method Validation and Technology Transfer using HPLC/UPLC
Author(s): Dhull Rohit, Kumar Sanjay, Jalwal Pawan
Abstract: High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. Impurities and degradation products to be separated are frequently not known and must be elucidated as part of the method development process. The developed HPLC methods need to meet stringent validation requirements before they are utilized for any pharmaceutical evaluations. Selectivity and detectability optimization have been the primary goals in HPLC separations for most of time; however, HPLC scientists who are not trained in the physical sciences are reluctant to use theoretical considerations in method development. Our philosophy for method development is always based upon many considerations. It varies with Product characteristics, experimental conditions and regulatory requirements. Agreement on what is required of the method should be obtained before method development begins. Performance characteristics of method requirements must be extensively studied before fixing of methods and there should be an approach always for continuous improvement. Method validation and method transfer requires a systematic approach. Peoples feel validation and transfer only as a test of the acceptability of method using prefixed conditions and acceptance criteria’s. However the real motive of method validation and transfer process is to challenge the method and determine limits of allowed variability for the conditions and specification values for meeting regulatory requirements while listening “voice of customer”.