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Bioequivalence Study of Simvastatin

Author(s): Selvadurai Muralidharan | Janaki Sankarachari Krishnan Nagarajan | Sachin Singh | Anil Dubala

Journal: Journal of Bioanalysis & Biomedicine
ISSN 1948-593X

Volume: 01;
Issue: 01;
Start page: 028;
Date: 2009;
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A simple, rapid and selective method was developed for estimationof simvastatin from human plasma. The method involves simple protein precipitation techniques using etofylline as internal standard. Chromatographic separation was carried out on a reversed phase C18 column using mixture of methanol: 2mM ammonium acetate and 500 μl of 0.5% formic acid (80:20, v/v) at a flow rate of 1.0 ml/min with UV-VIS detection at 418.35 nm. The retention time of simvastatin and internal standard were 5.41 and 1.086 min, respectively. The method was validated and found to be linear in the range of 1.0-10.0 ng/mL. An open, randomized, two-treatment, two period, single dose crossover, bioequivalence study in 12 fasting, healthy, male, volunteers was conducted. After dosing, serial blood samples were collected for the period of 24.0 h. Various pharmacokinetic parameters including AUC0–t, AUC0–∞ , Cmax, Tmax, T½, and elimination rate constant (Kel) were determined from plasma concentration of both formulations. Log transformed values were compared by analysis of variance (ANOVA) followed by classical 90% confidence interval for C , AUC0–t a nd AUC0–∞ and was found to be within the range. These results indicated that the analytical method was linear, precise and accurate. Test and reference formulation were found to be bioequivalent.
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