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丝裂霉素C污染的高效液相色谱-串联质谱法及擦拭程序验证

Validation of an HPLC-MS/MS and wipe procedure for mitomycin C contamination.

作者信息

B'Hymer Clayton, Connor Thomas, Stinson Derek, Pretty Jack

机构信息

U.S. Department of Health and Human Services, Centers for Disease Control, National Institute for Occupational Safety and Health, Division of Applied Research and Technology, Taft Laboratory C-23, 4676 Columbia Parkway, Cincinnati, OH 45226, USA

U.S. Department of Health and Human Services, Centers for Disease Control, National Institute for Occupational Safety and Health, Division of Applied Research and Technology, Taft Laboratory C-23, 4676 Columbia Parkway, Cincinnati, OH 45226, USA.

出版信息

J Chromatogr Sci. 2015 Apr;53(4):619-24. doi: 10.1093/chromsci/bmu095. Epub 2014 Aug 16.

DOI:10.1093/chromsci/bmu095
PMID:25129062
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4556226/
Abstract

A high-performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) method was developed for the determination of mitomycin C, an anticancer drug, from contamination on various surfaces. Mitomycin C is often used in various forms of intraperitoneal chemotherapy, and operating room healthcare worker exposure to this drug is possible. The surface testing method consisted of a wiping procedure utilizing a solution of 20/45/35 (v/v/v) of acetonitrile-isopropanol-water made 0.01 M in ammonium citrate (apparent pH 7.0). The wipe solutions were analyzed by means of HPLC-MS/MS using a reversed-phase gradient system and electrospray ionization in positive ion mode with a triple-quadrupole MS detector. Accuracy and precision of this method were demonstrated by a series of recovery studies of both spiked solutions and extracted wipes from various surfaces (stainless steel, vinyl and Formica(®)) spiked with known levels of mitomycin C. Recoveries of spiked solutions containing the analyte demonstrate mean recoveries (accuracy) ranged from 93 to 105%. Precision as measured by the relative standard deviation (% RSD) of multiple samples (n= 10) at each concentration level demonstrated values of 7.5% or less. The recoveries from spiked surfaces varied from 30 to 99%. The limit of detection for this methodology is ∼2 ng/100 cm(2) equivalent surface area, and the limit of quantitation is ∼6 ng/100 cm(2).

摘要

开发了一种高效液相色谱-串联质谱(HPLC-MS/MS)方法,用于测定各种表面污染物中的抗癌药物丝裂霉素C。丝裂霉素C常用于各种形式的腹腔化疗,手术室医护人员有可能接触到这种药物。表面检测方法包括擦拭程序,擦拭液为含有0.01 M柠檬酸铵(表观pH 7.0)的20/45/35(v/v/v)乙腈-异丙醇-水溶液。擦拭液通过HPLC-MS/MS进行分析,采用反相梯度系统和电喷雾电离,在正离子模式下使用三重四极杆质谱检测器。通过对添加了已知水平丝裂霉素C的加标溶液和从各种表面(不锈钢、乙烯基和富美家(®))提取的擦拭物进行一系列回收研究,证明了该方法的准确性和精密度。含有分析物的加标溶液的回收率表明平均回收率(准确度)在93%至105%之间。通过每个浓度水平的多个样品(n=10)的相对标准偏差(%RSD)测量的精密度表明,其值为7.5%或更低。加标表面的回收率在30%至99%之间。该方法的检测限约为2 ng/100 cm(2)等效表面积,定量限约为6 ng/100 cm(2)。

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