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Application of micellar electrokinetic chromatography to the quality control of a pharmaceutical preparation containing three bronchodilators
Author(s) -
Blanco Marcelo,
Valverde Ismael
Publication year - 2002
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/1522-2683(200202)23:4<578::aid-elps578>3.0.co;2-c
Subject(s) - micellar electrokinetic chromatography , chromatography , detection limit , chemistry , theophylline , sodium dodecyl sulfate , electrokinetic phenomena , electrolyte , pulmonary surfactant , medicine , biochemistry , electrode , endocrinology
Theophylline(1,3‐dimethylxanthine), dyphylline [7‐(2,3‐dihydroxypropyl)theophylline] and proxyphylline [7‐(β‐hydroxypropyl)theophylline] are three bronchodilators administered jointly in a single pharmaceutical preparation used against asthma. A micellar electrokinetic chromatography (MEKC) method for their resolution using a background electrolyte consisting of 20 m M tetraborate at pH 8.5 and 100 m M sodium dodecyl sulfate is proposed. The method was used to determine the three active principles in a pharmaceutical preparation. The small amount of sample required and the expeditiousness of the procedure allow content uniformity to be determined in individual tablets. The values of the validation parameters for the method ( viz. selectivity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness) are reported. A complete factor design (2 3 ×2) including pH, the surfactant concentration and the ionic strength of the background electrolyte as factors was used to estimate robustness. Based on the results, the method is robust enough for quantitation purposes.