A newfangled study using risk silhouette and uncertainty approximation for quantification of acyclovir in diverse formulation

作     者：Karan Mittal Riddhish Patadia Chintan Vora Rajashree C.Mashru 

作者机构：Pharmacy DepartmentFaculty of Technology and EngineeringThe Maharaja Sayajirao University of BarodaKalabhavanVadodara 390002GujaratIndia 

出 版 物：《Journal of Pharmaceutical Analysis》 (药物分析学报（英文版）)

年 卷 期：2015年第5卷第1期

页      面：58-69页

学科分类：0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 100706[医学-药理学] 1002[医学-临床医学] 0817[工学-化学工程与技术] 0703[理学-化学] 0702[理学-物理学] 10[医学] 100602[医学-中西医结合临床] 

主　　题：Acyclovir Risk profile Relative bias Combined standard uncertainty Expanded uncertainty 

摘      要：Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable ***,there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug *** the present work,evaluation of risk profile,combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were *** was calculated using cause-effect approach,and to make it more accurately applicable a method was validated in our laboratory as per the ICH *** assessing the results of validation,the calibration model was justified by the lack of fit and Levene＇s *** profile represents the future applications of this *** uncertainty the major contribution is due to sample concentration and *** work demonstrates the application of theoretical concepts of calibration model tests,relative bias,risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.