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

[摘要] 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.

[学科分类] 分析化学

[关键词] Cell lines study;LC-MS;risk profile;relative bias;combined standard uncertainty;expanded uncertainty