Pharmacy, Geneva University Hospitals (HUG), 1211 Geneva, Switzerland.
Anal Bioanal Chem. 2010 Dec;398(7-8):3033-42. doi: 10.1007/s00216-010-4243-1. Epub 2010 Oct 7.
A liquid chromatography separation with electrospray ionisation and tandem mass spectrometry detection method was developed for the simultaneous quantification of ten commonly handled cytotoxic drugs in a hospital pharmacy. These cytotoxic drugs are cytarabine, gemcitabine, methotrexate, etoposide phosphate, cyclophosphamide, ifosfamide, irinotecan, doxorubicin, epirubicin and vincristine. The chromatographic separation was carried out by RPLC in less than 21 min, applying a gradient elution of water and acetonitrile in the presence of 0.1% formic acid. MS/MS was performed on a triple quadrupole in selected reaction monitoring mode. The analytical method was validated to determine the limit of quantification (LOQ) and quantitative performance: lowest LOQs were between 0.25 and 2 ng mL(-1) for the ten investigated cytotoxic drugs; trueness values (i.e. recovery) were between 85% and 110%, and relative standard deviations for both repeatability and intermediate precision were always inferior to 15%. The multi-compound method was successfully applied for the quality control of pharmaceutical formulations and for analyses of spiked samples on potentially contaminated surfaces.
建立了一种液相色谱-电喷雾串联质谱检测法，用于同时定量测定医院药房中十种常用细胞毒性药物。这些细胞毒性药物包括阿糖胞苷、吉西他滨、甲氨蝶呤、依托泊苷磷酸酯、环磷酰胺、异环磷酰胺、伊立替康、多柔比星、表柔比星和长春新碱。在 RPLC 中，不到 21 分钟即可完成色谱分离，在 0.1%甲酸存在下，采用水和乙腈的梯度洗脱。MS/MS 在三重四极杆上以选择反应监测模式进行。对分析方法进行了验证，以确定定量限 (LOQ) 和定量性能：十种研究的细胞毒性药物的最低定量限 (LOQ) 在 0.25 和 2ng/mL 之间；准确度值（即回收率）在 85%至 110%之间，重复性和中间精密度的相对标准偏差始终低于 15%。该多化合物方法成功地应用于药物制剂的质量控制和潜在污染表面加标样品的分析。
