Development and application of a liquid chromatography coupled to mass spectrometry method for the simultaneous determination of 23 antineoplastic drugs at trace levels

J Pharm Biomed Anal. 2022 Nov 30:221:115034. doi: 10.1016/j.jpba.2022.115034. Epub 2022 Sep 8.

Abstract

The goal of this study was to develop a method for the simultaneous quantification of 23 commonly used antineoplastic drugs in a hospital pharmacy, using ultra-high pressure liquid chromatography separation coupled to tandem mass spectrometry detection (UHPLC-MS/MS). The following drugs were investigated: 5-fluorouracil, cytarabine, ganciclovir, gemcitabine, dacarbazine, methotrexate, pemetrexed, busulfan, topotecan, rentitrexed, ifosfamide, cyclophosphamide, etoposide, irinotecan, doxorubicin/epirubicin, vincristine, docetaxel, paclitaxel, daunorubicin, idarubicin, vinblastine, oxaliplatin and carboplatin. The chromatographic separation was performed on a phenyl-hexyl column (2.1 ×100 mm, 1.7 µm) with a gradient elution of methanol and water containing 10 mM ammonium formate adjusted to pH 4.9. All compounds were analyzed in less than 13 min and detected with a triple quadrupole mass spectrometer operating in MRM mode. Limits of detection (LODs) and limits of quantification (LOQs) were comprised between 0.01 and 5 ng.mL-1, and between 0.5 and 5 ng.mL-1, respectively. Accuracies ranged between 117% and 83% at the LOQ, intermediate and upper LOQ concentrations, with relative standard deviations (RSD) inferior to 8%, for all the antineoplastic drugs. Finally, the UHPLC-MS/MS method was successfully applied to the analysis of surface samples to evaluate the chemical contamination by these highly toxic compounds in a chemotherapy preparation unit in a hospital pharmacy with the purpose of monitoring the exposure of health care professionals.

Keywords: Antineoplastic drug; Mass spectrometry; Reversed phase liquid chromatography; Surface analyses; Trace analysis.

MeSH terms

  • Antineoplastic Agents* / analysis
  • Busulfan
  • Carboplatin
  • Chromatography, Liquid
  • Cyclophosphamide / analysis
  • Cytarabine
  • Dacarbazine
  • Daunorubicin
  • Docetaxel
  • Doxorubicin / analysis
  • Epirubicin
  • Etoposide
  • Fluorouracil
  • Ganciclovir
  • Humans
  • Idarubicin
  • Ifosfamide
  • Irinotecan
  • Methanol
  • Methotrexate
  • Oxaliplatin
  • Paclitaxel / analysis
  • Pemetrexed
  • Tandem Mass Spectrometry* / methods
  • Topotecan
  • Vinblastine
  • Vincristine
  • Water

Substances

  • Antineoplastic Agents
  • Cytarabine
  • Pemetrexed
  • Oxaliplatin
  • Water
  • Docetaxel
  • Epirubicin
  • Vincristine
  • Vinblastine
  • Etoposide
  • Irinotecan
  • Dacarbazine
  • Topotecan
  • Doxorubicin
  • Cyclophosphamide
  • Carboplatin
  • Busulfan
  • Paclitaxel
  • Ganciclovir
  • Fluorouracil
  • Ifosfamide
  • Methanol
  • Methotrexate
  • Idarubicin
  • Daunorubicin