HPLC-示差折光检测法测定盐酸克林霉素棕榈酸酯分散片含量的不确定度评定  

Evaluation of Measurement Uncertainty for the Content of Clindamycin Palmitate Hydrochloride Dispersion Tablets by HPLC-RID Method

作　　者：庞赛 刘晶晶 李玉兰 刘敏 王铁杰 PANG Sai;LIU Jingjing;LI Yulan;LIU Min;WANG Tiejie(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,深圳市药品质量标准研究重点实验室,广东深圳518057

出　　处：《中国医药导刊》2021年第10期743-747,共5页Chinese Journal of Medicinal Guide

摘　　要：目的:建立HPLC-示差折光检测法测定盐酸克林霉素棕榈酸酯分散片含量的不确定度评定方法,探讨影响含量测定的不确定度分量。方法:建立HPLC-示差折光检测法测定含量的数学模型,分析测量不确定度的来源,并对各分量进行量化分析和评估,合成标准测量不确定度,给出扩展测量不确定度报告。结果:HPLC-示差折光检测法测定盐酸克林霉素棕榈酸酯分散片含量为100.6%,置信概率为95%时,其扩展不确定度为0.7%,测量结果表示为(100.6±0.7)%,k=2。结论:建立HPLC-示差折光检测法测定含量的测量不确定度评定方法,分析产生不确定度的主要来源,为有效控制该含量测定方法的准确性提供可靠的理论依据。Objective:To establish uncertainty evaluation method for the content determination of clindamycin palmitate hydrochloride dispersion tablets by HPLC-RID method,and to identify the factors that affected its uncertainty.Methods:According to the detection process,the measurement model was established.The uncertainty sources were analyzed.Each active component in the uncertainty was calculated,and the expanded uncertainty was obtained.Results:HPLC-RID method showed the content of clindamycin palmitate hydrochloride dispersion tablets was 100.6%,confidence probability was 95%,and expanded uncertainty was 0.7%,and the determination result was(100.6±0.7)%,k=2.Conclusion:The method of the uncertainty evaluation for the content determination of clindamycin palmitate hydrochloride dispersion tablets by HPLC-RID method is established.The main sources of uncertainty are analyzed,which provide the reliable theoretical basis for effectively controlling of the content determination method.

关 键 词：HPLC-示差折光检测法 含量测定 盐酸克林霉素棕榈酸酯分散片 不确定度评定 

分 类 号：R927.3[医药卫生—药学]