高效液相色谱-串联质谱法测定化妆品中莫匹罗星等5种药物的不确定度评定

Evaluation of Uncertainty in the Determination of Five Drugs including Mupirocin in Cosmetics by HPLC-MS/MS

建立数学模型,分析了高效液相色谱-串联质谱法测定化妆品中莫匹罗星等5种药物的不确定度来源,包括样品称量及定容、样品测量重复性、对照品称量及稀释过程、标准曲线拟合等,并对各组分含量测定结果的不确定度进行评定。结果表明,化妆品中莫匹罗星、夫西地酸、噻吗洛尔、特比萘芬、红霉素质量分数分别为0.3218%、0.3185%、0.0320%、0.0159%、0.0164%时,其扩展不确定度分别为0.01674%、0.01720%、0.00186%、0.00090%、0.00092%,k=2。该评定为化妆品中莫匹罗星等5种组分的测量结果的准确性提供科学依据。

A mathematical model was established to analyze the sources of uncertainty in the determination of five drugs such as mupirocin in cosmetics by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS),including sample weighing and the volume measurement of sample solution,sample measurement repeatability,reference substance weighing and dilution process,standard curve fitting,etc.The uncertainty in the determination result of each component content was evaluated.The results showed that the extended uncertainties of mupirocin,fusidic acid,timolol,terbinafine,and erythromycin were 0.01674%,0.01720%,0.00186%,0.00090%and 0.00092%(k=2)when their concents in cosmetics were 0.3218%,0.3185%,0.0320%,0.0159%and 0.0164%.This evaluation provides a scientific basis for the accuracy of the measurement results of five components in cosmetics,including mupirocin.