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Validation of a capillary zone electrophoresis method for the comparative determination of etoricoxib in pharmaceutical formulations

✍ Scribed by Sérgio Luiz Dalmora; Maximiliano da Silva Sangoi; Lucélia Magalhães da Silva; Rui Oliveira Macedo; Thiago Barth


Publisher
John Wiley and Sons
Year
2008
Tongue
English
Weight
258 KB
Volume
31
Category
Article
ISSN
1615-9306

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✦ Synopsis


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).


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