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

• Published in: Journal of separation science Vol. 31; no. 1; pp. 169 - 176
• Main Authors: Dalmora, Sérgio Luiz, da Silva Sangoi, Maximiliano, da Silva, Lucélia Magalhães, Oliveira Macedo, Rui, Barth, Thiago
• Format: Journal Article
• Language: English
• Published: Weinheim Wiley-VCH Verlag 2008; WILEY-VCH Verlag; WILEY‐VCH Verlag; Wiley
• Subjects: Analysis; Biological and medical sciences; Capillary zone electrophoresis; Chemistry, Pharmaceutical; Dosage Forms; Electrophoresis, Capillary - methods; Etoricoxib; General pharmacology; Liquid chromatography; Medical sciences; Molecular Structure; Pharmaceutical analysis; Pharmacology. Drug treatments; Pyridines - analysis; Pyridines - chemistry; Sulfones - analysis; Sulfones - chemistry; Validation; Prostaglandin-endoperoxide synthase; Tandem mass spectrometry; Chemical analysis; Zone electrophoresis; Etoricoxib; Cyclooxygenase 2; HPLC chromatography; Cyclooxygenase 2 inhibitor; Electrospray; Tablet; Quantitative analysis; Validation; Pharmaceutical analysis /Validation; Capillary zone electrophoresis; Enzyme; Capillary electrophoresis; Coupled method; Enzyme inhibitor; Oral form; Liquid chromatography; Non steroidal antiinflammatory agent; Ultraviolet detector; Dosage form; Oxidoreductases; Comparative study
• ISSN: 1615-9306; 1615-9314
• DOI: 10.1002/jssc.200700272

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 (r² = 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).