Development of a validated LC-APCI-MS/MS method to study the plasma and tumor distribution of CHO-PTX intravenous lipid emulsion

J Pharm Biomed Anal. 2016 Jan 5:117:532-43. doi: 10.1016/j.jpba.2015.05.023. Epub 2015 May 28.

Abstract

Conjugation of a cholesterol moiety to active compounds for cancer treatment or diagnosis is an attractive approach for increasing lipophilicity and improving loading into lipid carriers. We developed a highly sensitive and specific liquid chromatography atmospheric-pressure chemical ionization tandem mass spectrometry (LC-APCI-MS/MS) analytical method to investigate the in vivo plasma and tumor distribution characteristic of a cholesterol-paclitaxel conjugate (CHO-PTX) in nude mice with MDA-MB-231 human breast cancer xenografts. The samples were analyzed in positive ion, multiple reaction monitoring mode. The plasma and tumor tissue samples were processed by liquid-liquid extraction with methyl tert-butyl ether (MTBE). Docetaxel was used as the internal standard (IS) for sample processing and analysis. MS/MS detection was carried out by monitoring the transitions of m/z 1266.7→369.4 and 330.3 for CHO-PTX, and m/z 808.7→226.4 and 509.1 for IS. The calibration curves were linear over 100-25,000 ng/mL in mouse plasma and tumor homogenate samples. The limit of quantitation of CHO-PTX was 100 ng/mL in both matrices. The intra-day and inter-day precisions were less than 15%, and the accuracy was between -8.0% and 8.6% for both matrices. The developed method was successfully applied to measure CHO-PTX levels in plasma and tumor tissues in nude mice. The mean tumor concentrations in mice tumor tissues after intravenous administration of CHO-PTX emulsion at a dose equivalent to 20 mg/kg paclitaxel were 2022±630 ng/mL ng/mL, 2516±982 ng/mL, 3056±1438 ng/mL, and 2367±1029 ng/mL at 0.25, 3, 24, and 120 h, respectively. The accumulation of CHO-PTX in the tumor suggests that cholesteryl drug conjugates are a promising approach for medical treatment of various human cancers.

Keywords: Bioanalytical method; Cholesterol-paclitaxel conjugate; Emulsion; LC–APCI-MS/MS; Tumor-bearing mouse.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Atmospheric Pressure
  • Cholesterol / administration & dosage
  • Cholesterol / metabolism*
  • Chromatography, Liquid / methods
  • Chromatography, Liquid / standards
  • Fat Emulsions, Intravenous / administration & dosage
  • Fat Emulsions, Intravenous / analysis
  • Fat Emulsions, Intravenous / metabolism*
  • Female
  • Humans
  • Mice
  • Mice, Inbred BALB C
  • Mice, Nude
  • Neoplasms / drug therapy
  • Neoplasms / metabolism*
  • Paclitaxel / administration & dosage
  • Paclitaxel / metabolism*
  • Reproducibility of Results
  • Tandem Mass Spectrometry / methods*
  • Tandem Mass Spectrometry / standards

Substances

  • Fat Emulsions, Intravenous
  • Cholesterol
  • Paclitaxel