高效液相色谱法测定清开灵注射液中栀子苷含量不确定度的评定  

Analysis of Measurement Uncertainty in Determination of Geniposide in Qingkailing Injection by HPLC

作　　者：陈佳[1] 陈骁鹏[1] 郭玮璐 CHEN Jia;CHEN Xiao-peng;GUO Wei-lu(Taizhou Institute for Food and Drug Control,Taizhou 225300,China;HuaiHai Institute of Technology,Lianyungang 222000,China)

机构地区：[1]江苏省泰州市食品药品检验所,泰州225300 [2]江苏省淮海工学院,连云港222000

出　　处：《海峡药学》2018年第7期83-85,共3页Strait Pharmaceutical Journal

摘　　要：目的对HPLC法测定清开灵注射液中栀子苷含量的不确定度分析,找出影响不确定度的因素。方法根据含量测定不确定度的数学模型,对各个不确定度分量进行计算。结果本法测量扩展不确定度为3×10^(-3)mg·mL^(-1),测量结果表示为(0.267±3×10^(-3))mg·mL^(-1),k=2。结论本法的测量不确定度主要由对照品称量和对照品溶液稀释所引入,为有效地控制该含量测定方法的准确性提供可靠的理论依据。OBJECTIVE To find out the impacting factors in uncertainty by analyzing the measurement uncer- tainty in the determination of Geniposide in Qingkailing Injection by HPLC and provide the evidence for the measure- ment evaluation. METHODS A mathematic model for calculating uncertainty was established, and every component in the uncertainty was assessed. RESULTS The expanded uncertainty for the content determination of Geniposide in Qingkailing Injection as 3 x 10-3mg·mL^（-1） ,and the result of content determination was 0. 267 ± 3 x 10-3mg · mL-1（ k = 2）. CONCLUSION The measurement uncertainty of the experiment is mainly caused by the eference substance weight and solution dilution, which can provide theory evidence for accuracy control of the measurement method.

关 键 词：清开灵注射液 栀子苷 高效液相色谱法 含量测定 测量不确定度 

分 类 号：R927[医药卫生—药学]