Determination of sodium cromoglycate in human plasma by liquid chromatography with tandem mass

Biomed Chromatogr. 2008 Sep;22(9):1021-7. doi: 10.1002/bmc.1022.

Abstract

A sensitive and selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed and validated for the determination of sodium cromoglycate (SCG) in human plasma after a nasal dose of 10.4 mg sodium cromoglycate nasal spray, using pravastatin sodium as the internal standard. The method was validated over a linear range of 0.300-20.0 ng/mL. SCG and I.S. were extracted from 1.0 mL of heparinized plasma by C(18) solid-phase extraction cartridges using methanol as eluting solvent. The dried residue was reconstituted with 100 microL of mobile phase, and 10 microL was injected onto the LC-MS/MS system. Chromatographic separation was achieved on a C(18) column (250 x 4.6 mm i.d., 5 microm particle size) with a mobile phase of methanol-acetonitrile-water (containing 2 mmol/L ammonium acetate; 42.5:42.5:15, v/v/v) at a flow rate of 0.4 mL/min. The analytes were detected with a triple quad LC-MS/MS using ESI with positive ionization. Ions monitored in the multiple reaction monitoring mode were m/z 469.0 (precursor ion) to m/z 245.0 (product ion) for SCG and m/z 447.2 (precursor ion) to m/z327.1 (product ion) for pravastatin sodium (internal standard) The average recovery of SCG from human plasma was 94.88% and the lower limit of quantitation was 0.3 ng/mL. Results from a 3-day validation study demonstrated excellent precision and accuracy across the calibration range of 0.3-20 ng/mL. The method was successfully applied to the pharmacokinetic study of SCG in healthy Chinese volunteers.

Publication types

  • Validation Study

MeSH terms

  • Anti-Asthmatic Agents / blood*
  • Anti-Asthmatic Agents / chemistry
  • Anti-Asthmatic Agents / pharmacokinetics
  • Chromatography, Liquid / methods*
  • Cromolyn Sodium / blood*
  • Cromolyn Sodium / chemistry
  • Cromolyn Sodium / pharmacokinetics
  • Humans
  • Sensitivity and Specificity
  • Tandem Mass Spectrometry / methods*

Substances

  • Anti-Asthmatic Agents
  • Cromolyn Sodium