摘要
目的:探讨利巴韦林注射液中利巴韦林的 HPLC 定量分析方法的测量不确定度的评定方法。方法:通过分析测量过程,确定并简化不确定度来源;利用 HPLC 法测定利巴韦林注射液中利巴韦林的方法验证数据及经验数据,通过统计学方法,量化不确定度分量;计算合成不确定度和扩展不确定度。结果:用 HPLC 法测定利巴韦林注射液中利巴韦林的扩展不确定度为1.6%×Q%。结论:测量不确定度可用于利巴韦林的液相方法的评价;测量不确定度的评定方法的确立对于药品质量标准的研究具有重要意义。
Objective：To set out the procedure for estimation of measurement uncertainty for the determination of ribavirin by HPLC. Methods： To facilitate the identification and analysis of the uncertainty sources arising from the procedure of analysis, a cause and effect diagram was constructed and simplified. Each uncertainty component, whether associated with individual sources or with the combined effects of several sources, was evaluated with respect to the significance of its contribution to the overall measurement uncertainty and was expressed as standard uncertainty. Al1 the standard uncertainties were then combined according to the appropriate rules to give a combined standard uncertainty and an expanded standard uncertainty. Results： The expanded standard uncertainties for the HPLC determination of ribavirin in injections is 1.6% × Q%. Conclusion： Measurement uncertainty is applicable to set the limit of the ribavirin in injections. The establishment of the methodology for the evaluation of measurement uncertainty is important to the studies of Chinese medical standards.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第11期1803-1805,共3页
Chinese Journal of Pharmaceutical Analysis
