Risk outlining and uncertainty contour for quantification of acyclovir using LC-MS: solicitation to In Vitro cell line studies

Abstract

Outlining of risk profile and uncertainty estimation are the two chief and significant strictures that
need to be adopted during the development of pharmaceutical process, to ensure reliable results. In
this era, the conventional method validation agenda needs to be extemporized so as to certify
extraordinary method reliability to measure quality attribute of a drug product. In this research work,
risk sketch and expanded uncertainty in the analysis of acyclovir were studied. LC-MS method was
validated in our laboratory as per ICH guidelines and risk profile has been outlined including
uncertainty estimation using the cause-effect approach. In the course of validation, the calibration
model found to be defensible when encountered with Levene’s and lack of fit test. The proposed
research work evidently demonstrates the application of theoretical concepts of uncertainty and risk
profile in the methods used for analysis in drug discovery process