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

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

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).

MeSH terms

  • Chromatography, High Pressure Liquid / methods*
  • Decontamination / instrumentation
  • Decontamination / methods*
  • Decontamination / standards
  • Environmental Monitoring / methods*
  • Humans
  • Limit of Detection
  • Linear Models
  • Mitomycin / analysis*
  • Occupational Exposure / prevention & control*
  • Reproducibility of Results
  • Tandem Mass Spectrometry / methods*

Substances

  • Mitomycin