Separation of ibuprofen, codeine phosphate, their degradation products and impurities by capillary electrophoresis. II. Validation.
A micellar electrokinetic chromatography method for the determination of ibuprofen and codeine phosphate hemihydrate and their degradation products and impurities in a commercial tablet formulation has been validated. The validation has been performed according to the International Conference of Harmonisation's guidance on the validation of analytical methods, and selectivity, linearity, accuracy, precision, detection limit, quantitation limit, robustness and range test were performed to determine the suitability of the method. It was possible to use the fractional factorial design model from the optimisation of the method to draw conclusions about its robustness. The results confirm that the method is highly suitable for its intended purpose.
Stubberud
K P
KP
Analytical and Pharmaceutical R & D, Astra Arcus AB, Södertälje, Sweden. karin.stubberud@arcus.se.astra.com
Aström
O
O
D002626:Chemistry, Pharmaceutical / Q000592:standards*; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000592:standards*; D003061:Codeine / Q000032:analysis*; D004338:Drug Combinations; D004340:Drug Contamination; D019075:Electrophoresis, Capillary / Q000592:standards*; D007052:Ibuprofen / Q000032:analysis*; D015203:Reproducibility of Results; D013607:Tablets
D004338:Drug Combinations; D013607:Tablets; D003061:Codeine; D007052:Ibuprofen