A simple and sensitive HPLC-UV method for quantitation of lovastatin in human plasma: application to a bioequivalence study.
An available, simple, sensitive, and rapid method has been developed for determination of the 3-hydroxy-3-methylglutaryl (HMG)-CoA reductase inhibitor, lovastatin in human plasma. The analytical procedure involves a one-step liquid-liquid extraction method using atorvastatin as internal standard. Chromatographic separation was carried out on a reversed phase C(18) column using a mixture of 0.05 M phosphate buffer (pH 7) and acetonitrile (44.5 : 55.5, v/v) as mobile phase with UV detection set at 238 nm. The total run time of analysis was 6 min with the retention time of lovastatin being 4.3 min. A complete set of analytical method validation tests were carried out on the method. Accordingly, the method was linear in the wide range of 1-100 ng/ml. The limit of detection (LOD) and limit of quantification (LOQ) for lovastatin were 0.5 and 1 ng/ml, respectively. The method was shown to be precise with average within-run and between-run variations of 10.45+/-6.88 and 8.68+/-5.13%, respectively. The average within-run and between-run accuracy of the method throughout its linear range was 113.33+/-3.98 and 105.72+/-5.07%, respectively. The mean relative recovery of lovastatin from human plasma by the developed method was 88.61+/-7.00%. The applicability of the method in real pharmacokinetic situations was evaluated successfully during a bioequivalence study in 14 fasting healthy male volunteers.
Hamidi
Mehrdad
M
Department of Pharmaceutics, Shiraz University of Medical Sciences, Iran. hamidim@zums.ac.ir
Zarei
Najmeh
N
Shahbazi
Mohammad-Ali
MA
D000704:Analysis of Variance; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000097:blood / Q000493:pharmacokinetics / Q000592:standards; D008148:Lovastatin / Q000097:blood* / Q000493:pharmacokinetics* / Q000592:standards; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet / Q000379:methods / Q000592:standards; D013810:Therapeutic Equivalency; D055815:Young Adult
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008148:Lovastatin