title: Capillary electrophoretic separation of N-acetylcysteine and its impurities as a method for quality control of pharmaceuticals.
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%.
authors.affiliation: Department of Biological Preparations, Drug Institute, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Jaworska
authors.forename: G
authors.initials: G
authors.lastname: Szulińska
authors.forename: M
authors.initials: M
authors.lastname: Wilk
authors.forename: J
authors.initials: J
authors.lastname: Tautt
mesh_terms: D000111:Acetylcysteine / Q000032:analysis* / Q000138:chemical synthesis; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D004345:Drug Industry; D019075:Electrophoresis, Capillary / Q000379:methods*; D005100:Expectorants / Q000032:analysis / Q000138:chemical synthesis; D006863:Hydrogen-Ion Concentration; D011786:Quality Control
chemical_list: D005100:Expectorants; D000111:Acetylcysteine