Ezetimibe is the drug of choice from the novel class of anti-hyperlipidemic drugs. An analytical literature survey for the determination of ezetimibe revealed few articles based on different techniques. However, there is a need of a suitable analytical technique that will be simple and reproducible. A reversed-phase HPLC method was developed to quantify the ezetimibe in the presence of degradation products and pharmaceutical excipients. A stress study was performed on ezetimibe. The separation was carried out on Waters Spherisorb CNRP column using acetonitrile: water (40:60 v: v) as a mobile phase with a flow rate of 1 ml/min. The wavelength of the detection was set at 232 nm. The calibration curve for ezetimibe was found linear (R2=0.999) in the concentration range 5-30 microgram/ml. The relative standard deviation for all the key parameters (selectivity, specificity, linearity, accuracy and precision) was found to be less than 2%. The recovery of the drug after standard addition was found in the range of 95.15-96.30 %. Stress study showed complete degradation in alkaline conditions, whereas less degradation was observed in acidic, thermal, oxidizing and photolytic conditions. The developed RP-HPLC method would be suitable for the identification and quantification of ezetimibe in various pharmaceutical dosage forms.
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