Development and validation of a reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms.
Ezetimibe belongs to a group of selective and very effective 2-azetidione cholesterol absorption inhibitors that act on the level of cholesterol entry into enterocytes. A rapid, specific reversed-phase HPLC method has been developed for assaying ezetimibe in pharmaceutical dosage forms. The assay involved an isocratic elution of ezetimibe in a Kromasil 100 C18 column using a mobile phase composition of water (pH 6.8, 0.05%, w/v 1-heptane sulfonic acid) and acetonitrile (30:70, v/v). The flow rate was 0.5 ml/min and the analyte monitored at 232 nm. The assay method was found to be linear from 0.5 to 50 microg/ml. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of ezetimibe in tablets.
Sistla
R
R
Pharmacology Division, Indian Institute of Chemical Technology, Uppal Road, Tarnaka, Hyderabad 500007, India.
Tata
V S S K
VS
Kashyap
Y V
YV
Chandrasekar
D
D
Diwan
P V
PV
D000097:Acetonitriles / Q000737:chemistry; D000924:Anticholesteremic Agents / Q000032:analysis* / Q000737:chemistry*; D001384:Azetidines / Q000032:analysis* / Q000737:chemistry*; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004345:Drug Industry / Q000379:methods*; D004355:Drug Stability; D020895:Enterocytes / Q000378:metabolism; D000069438:Ezetimibe; D006536:Heptanes / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D006937:Hypercholesterolemia / Q000473:pathology; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000032:analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013451:Sulfonic Acids / Q000737:chemistry; D013607:Tablets; D013696:Temperature; D013997:Time Factors; D014466:Ultraviolet Rays
D000097:Acetonitriles; D000924:Anticholesteremic Agents; D001384:Azetidines; D006536:Heptanes; D004364:Pharmaceutical Preparations; D013451:Sulfonic Acids; D013607:Tablets; D000069438:Ezetimibe; C032159:acetonitrile