摘要
目的:对人血浆万古霉素浓度高效液相色谱法(HPLC)测定的不确定度进行评定。方法:对HPLC法测定血浆中万古霉素浓度的全过程进行分析,对于分析过程中称量过程、溶液配制、萃取过程、仪器及标准曲线拟合等因素带来的不确定度进行逐一分析,用A类评定程序评定了分析过程中随机效应引起的不确定度,用B类评定程序评定了分析过程中其他因素引起的不确定度,根据合成不确定度的公式计算出合成不确定度并进行了扩展。结果:置信概率P为95%时,血浆中低(8.44μg/mL)、中(54.22μg/mL)、高(171.63μg/mL)浓度万古霉素的扩展不确定度分别是2.57μg/mL,7.66μg/mL,24.03μg/mL。结论:线性拟合过程是本实验中低浓度时不确定度的主要来源,而中、高浓度时标准曲线配制是不确定度的主要来源。本方法可用于HPLC法测定血浆中万古霉素浓度的不确定度评定,为药物分析过程中的不确定度评定提供了参考。
Objective： To evaluate the uncertainty of vancomycin determination in numan plasma by HPLC. Methods： Uncertainty caused by various factors in the process of determination, including preparation of standard solution, extraction, calibration fitting and the accuracy of the equipment were analyzed. Uncertainty caused by random effects was evaluated by type A evaluation protocol and other effects were evaluated by type B protocol. The combined uncertainty was calculated with all the components. Results： The expanded uncertainty of vancomycin in low （8.44μg/mL）, medium （54.22μg/mL） and high （171.63μg/mL） level was 2.57μg/mL, 7.66μg/mL, and 24.03μg/mL, respectively （P=95%）. Conclusion： Standard curve fitting wasthe main source of uncertaintyfor the determination of vancomycin at low concentration and standard solution preparation was the main source of uncertainty for the medium and high concentration of vancomycin. This method could be used to evaluate the uncertainty of vancomycin determination in human plasma. Reference was also provided for the uncertainty evaluation in drug analysis.
出处
《药品评价》
CAS
2013年第20期31-35,共5页
Drug Evaluation
