Simultaneous liquid chromatographic determination of ezetimibe and simvastatin in pharmaceutical products.
A reversed-phase liquid chromatographic (LC) method was developed and validated for the simultaneous determination of ezetimibe and simvastatin in pharmaceutical dosage forms. The LC method was carried out on a Synergi fusion C18 column (150 mm x 4.6 mm id) maintained at 45 degrees C. The mobile phase consisted of phosphate buffer 0.03 M, pH 4.5-acetonitrile (35 + 65, v/v) run at a flow rate of 0.6 mL/min, and detection was made using a photodiode array detector at 234 nm. The chromatographic separation was obtained within 15.0 min, and calibration graphs were linear in the concentration range of 0.5-200 microg/mL. Validation parameters such as specificity, linearity, precision, accuracy, and robustness were evaluated, giving results within the acceptable range for both compounds. Moreover, the proposed method was successfully applied for the routine quality control analysis of pharmaceutical products.
Oliveira
Paulo Renato
PR
Federal University of Santa Maria, Health Science Centre, Department of Industrial Pharmacy, 97.105-900 Santa Maria-RS, Brazil.
Barth
Thiago
T
Todeschini
Vitor
V
Dalmora
Sérgio Luiz
SL
D000924:Anticholesteremic Agents / Q000032:analysis*; D001384:Azetidines / Q000032:analysis*; D002853:Chromatography, Liquid; D004338:Drug Combinations; D000069438:Ezetimibe; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis*; D007202:Indicators and Reagents; D012015:Reference Standards; D015203:Reproducibility of Results; D019821:Simvastatin / Q000032:analysis*; D012996:Solutions; D013607:Tablets
D000924:Anticholesteremic Agents; D001384:Azetidines; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D019821:Simvastatin; D000069438:Ezetimibe