Application of a capillary electrophoresis method for simultaneous determination of preservatives in pharmaceutical formulations

Preservatives are used to protect pharmaceutical formulations from microbial attack during the period of administration to the patient. Because of their biological activity, preservatives have to be identified and assayed according to the same rules as apply to active components. A number of methods...

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Bibliographic Details
Published in:Journal of separation science 2005-02, Vol.28 (2), p.137-143
Main Authors: Jaworska, Małgorzata, Szulińska, Zofia, Wilk, Małgorzata
Format: Article
Language:English
Subjects:
Analysis
Benzyl alcohol
Benzyl Alcohol - analysis
Biological and medical sciences
Chlorobutanol
Chlorobutanol - analysis
Chromatography, Micellar Electrokinetic Capillary - instrumentation
Chromatography, Micellar Electrokinetic Capillary - methods
Cresols - analysis
Electrophoresis, Capillary - methods
General pharmacology
Hydrogen-Ion Concentration
m-Cresol
Medical sciences
Method validation
m‐Cresol, Thimerosal
Parabens
Parabens - analysis
Pharmaceutical analysis
Pharmaceutical Preparations - analysis
Pharmacology. Drug treatments
Phenol
Phenol - analysis
Preservatives
Preservatives, Pharmaceutical - analysis
Reproducibility of Results
Sodium Dodecyl Sulfate - pharmacology
Temperature
Thimerosal
Thimerosal - analysis
Time Factors
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Summary:Preservatives are used to protect pharmaceutical formulations from microbial attack during the period of administration to the patient. Because of their biological activity, preservatives have to be identified and assayed according to the same rules as apply to active components. A number of methods for separation of preservatives are reported, to account for the heterogeneity of their chemical structures. A capillary electrophoretic method was devised for simple and simultaneous qualification and quantification of the preservatives most often included in pharmaceuticals, such as benzyl alcohol, parabens, phenol, m‐cresol, chlorobutanol, thimerosal. After systematic method development, the electrophoretic conditions were defined as: 50 mM borate buffer pH 9.0 containing 20 mM SDS. Separations were performed at a temperature of 20°C and with detection at 214 nm. Preservatives under examination can be analyzed within a 10 min run. The method was successfully validated and applied to the determination of preservatives in a number of pharmaceuticals. Results from the CE method were compared with those from reference methods.
ISSN:1615-9306
1615-9314
DOI:10.1002/jssc.200401785