Validation of a capillary zone electrophoresis method for the comparative determination of etoricoxib in pharmaceutical formulations.
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 microm 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 degrees 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 microg/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 microg/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).
Dalmora
Sérgio Luiz
SL
Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria, RS, Brazil. sdalmora@terra.com.br
Sangoi
Maximiliano da Silva
Mda S
da Silva
Lucélia Magalhães
LM
Macedo
Rui Oliveira
RO
Barth
Thiago
T
D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D019075:Electrophoresis, Capillary / Q000379:methods*; D000077613:Etoricoxib; D015394:Molecular Structure; D011725:Pyridines / Q000032:analysis* / Q000737:chemistry*; D013450:Sulfones / Q000032:analysis* / Q000737:chemistry*
D004304:Dosage Forms; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib