Precise determination of N-acetylcysteine in pharmaceuticals by microchip electrophoresis

J Sep Sci. 2016 Jan;39(2):433-9. doi: 10.1002/jssc.201501025. Epub 2015 Nov 24.

Abstract

A novel microchip electrophoresis method for the rapid and high-precision determination of N-acetylcysteine, a pharmaceutically active ingredient, in mucolytics has been developed. Isotachophoresis separations were carried out at pH 6.0 on a microchip with conductivity detection. The methods of external calibration and internal standard were used to evaluate the results. The internal standard method effectively eliminated variations in various working parameters, mainly run-to-run fluctuations of an injected volume. The repeatability and accuracy of N-acetylcysteine determination in all mucolytic preparations tested (Solmucol 90 and 200, and ACC Long 600) were more than satisfactory with the relative standard deviation and relative error values <0.7 and <1.9%, respectively. A recovery range of 99-101% of N-acetylcysteine in the analyzed pharmaceuticals predetermines the proposed method for accurate analysis as well. This work, in general, indicates analytical possibilities of microchip isotachophoresis for the quantitative analysis of simplified samples such as pharmaceuticals that contain the analyte(s) at relatively high concentrations.

Keywords: Conductivity detection; Isotachophoresis; Microchip electrophoresis; Mucolytics; N-Acetylcysteine.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetylcysteine / analysis*
  • Electrophoresis, Microchip / methods*
  • Pharmaceutical Preparations / analysis*

Substances

  • Pharmaceutical Preparations
  • Acetylcysteine