质控图联合Westgard多规则法在SPE-HPLC-DAD测定伏立康唑血药浓度方法中的应用  

Application of quality control chart combined with Westgard multi-rule method in detection of concentration of voriconazole in human plasma by SPE-HPLC-DAD

作　　者：肖润梅 王星翘 何秋月 Xiao Runmei;Wang Xingqiao;He Qiuyue(Department of Pharmacy,Hubei Provincial Hospital of Integrated Chinese and Western Medicine,Wuhan 430015,Hubei,China)

机构地区：[1]湖北省中西医结合医院药学部,湖北武汉430015

出　　处：《实用检验医师杂志》2022年第2期195-199,共5页Chinese Journal of Clinical Pathologist

基　　金：湖北省卫生健康委卫生健康科研项目(WJ2021F125)。

摘　　要：目的建立固相萃取柱净化高效液相二极管阵列检测法(SPE-HPLC-DAD)测定人血清伏立康唑血药浓度的实验方法,通过质控图和Westgard多规则法联合应用进行室内质控评估。方法以甲硝唑为内标,使用Agela Cleanert S C_(18)固相萃取柱处理血样,Hypersil C_(18)柱作为分析柱。检测波长为254 nm,进样量为30μL,柱温30℃,考察该方法的标准曲线与专属性、定量下限、精密度与回收率。收集2021年1—12月湖北省中西医结合医院伏立康唑血清治疗药物浓度监测(TDM)的室内质控结果,分别绘制Levey-Jennings质控图和Z分数质控图,采用Westgard多规则法对质控进行评价。结果内标和伏立康唑的保留时间分别为5.74 min和7.65 min,无其他物质干扰测定,伏立康唑血药浓度在0.44~14.00 mg/L范围内线性关系良好(r=0.9992);低、中、高3种浓度的样本回收率分别为101.80%、94.80%、100.10%;日内精密度相对标准偏差(RSD)为1.98%~3.57%,日间精密度RSD为2.26%~5.00%,稳定性RSD为2.20%~6.40%,2021年1—12月质控样品的批间RSD小于15.00%,符合《9012生物样品定量分析方法指导原则》,各质控样品的实际检测结果均可控。结论该院建立的测定伏立康唑血药浓度方法敏感度较高,操作简便;质控图在TDM室内质控中能更合理、有效地进行质控,合理用药,提高临床医生及患者对TDM的信任度。Objective To establish a method for determination of the concentration of voriconazole in human plasma by solid phase extraction-high performance liquid chromatography-diode array detection(SPE-HPLC-DAD)and using quality control chart and Westgard multi-rule method to perform interior quality control.Methods Using metronidazole as internal standard,Agela Cleanert S C_(18) column was used as solid phase extraction column and Hypersil C_(18) column was used as analytical column.The detecting wavelength was at 254 nm,with the injection volume of 30μL and the column temperature at 30℃.The standard curve,specificity,quantification lower limit,precision and recovery rate of the method were explored.The interior quality control results of voriconazole serum therapeutic drug concentration monitoring(TDM)in Hubei Provincial Hospital of Integrated Chinese and Western Medicine from January to December 2021 were collected,Levey-Jennings quality control chart and Z-score quality control chart were drawn respectively,and were evaluated with Westgard multi-rule method.Results The retention time of internal standard and voriconazole were 5.74 minutes and 7.65 minutes.No other substances interfered with the determination.The concentration of voriconazole showed a good linearity in the range of 0.44-14.00 mg/L(r=0.9992).The method recovery rates of voriconazole at low,medium and high concentration were 101.80%,94.80% and 100.10%.The values of intra-day relative standard deviation(RSD)were 1.98%-3.57% and the inter-day RSD values were 2.26%-5.00%.RSD values of stability were 2.20%-6.40%.RSD of quality control data in January to December,2021 were less than 15.00%,which were accorded with the requirement of 9012 Guidelines for Quantitative Analysis of Biological Samples.The quality control was basically accorded with the normal distribution,and all the quality control data were in control.Conclusion The method was specific suitable,simply andstable for determination of voriconazole in human serum,rational use of interior quality

关 键 词：伏立康唑 C_(18)固相萃取柱 高效液相色谱 质量控制图 

分 类 号：R969[医药卫生—药理学]