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Capillary electrophoretic separation ofN-acetylcysteine and its impurities as a method for quality control of pharmaceuticals

Authors
Journal
Journal of Chromatography A
0021-9673
Publisher
Elsevier
Publication Date
Volume
853
Identifiers
DOI: 10.1016/s0021-9673(99)00727-x
Keywords
  • Acetylcysteine
  • Cystine
  • Cysteine
Disciplines
  • Pharmacology

Abstract

Abstract Capillary electrophoresis has been applied to separate and determine N-acetylcysteine (NAC) and related impurities. Determination conditions were found to be optimum with 100 mmol/l borate as the buffer, pH 8.40. The limit of detection was established for each substance examined. The method has been validated by examining linearity ranges, precision and repeatability. The method was used to determine the content of NAC in, and purity of, pharmaceutical preparations. The major impurities (N,N-diacetylcystine, N,S-diacetylcysteine and cystine) were determined at levels of 0.1%.

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