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Validation of a capillary zone electrophoresis method for the comparative determination of etoricoxib in pharmaceutical formulations
Author(s) -
Dalmora Sérgio Luiz,
da Silva Sangoi Maximiliano,
da Silva Lucélia Magalhães,
Oliveira Macedo Rui,
Barth Thiago
Publication year - 2008
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200700272
Subject(s) - etoricoxib , chromatography , capillary electrophoresis , chemistry , dosage form , detection limit , accuracy and precision , capillary action , analytical chemistry (journal) , quantitative analysis (chemistry) , phosphate buffered saline , materials science , mathematics , statistics , organic chemistry , composite material
Abstract A CZE method was developed and validated for the analysis of etoricoxib in pharmaceutical dosage forms, using prilocaine as an internal standard. The CZE method was carried out on a fused‐silica capillary (50 μm id, effective length 40 cm). The BGE consisted of 25 mM tris‐phosphate solution at pH 2.5. The capillary temperature was maintained at 35°C, the applied voltage was 25 kV, the injection was performed using the pressure mode at 50 mbar for 5 s, with detection at 234 nm using a photodiode array detector. The method was linear in the range of 2–150 μg/mL ( r 2 = 0.9999). The specificity and stability‐indicating capability were proven through the degradation studies and showing also that there was no interference of the excipients of the formulation. The accuracy was 99.49% with RSD of 0.66%. The limits of quantitation and detection were 2 and 0.58 μg/mL, respectively. Moreover, method validation demonstrated acceptable results for the precision, sensitivity, and robustness. The proposed method was successfully applied for the quantitative analysis of etoricoxib pharmaceutical formulations, and the results compared to the HPLC and LC‐MS/MS methods, showing nonsignificant difference ( p >0.05).