Bioequivalence Study of Simvastatin |
| Selvadurai Muralidharan1, Janaki Sankarachari Krishnan Nagarajan1*, Sachin Singh1, and Anil Dubala1 |
1Department of Pharmaceutical Analysis, J.S.S.College of Pharmacy, Tamilnadu, India |
| *Corresponding author: |
Dr. Janaki Sankarachari Krishnan Nagarajan,
Center for Advanced Drug Research and Testing, J.S.S.College of pharmacy,
Tamilnadu, India,
Tel: +91-423-2443393,
Fax : +91-423-2442937,
E-mail: nagasaki2001@rediffmail.com |
|
| Received October 05, 2009; Accepted December 24, 2009; Published December 24, 2009 |
Citation: Muralidharan S, Nagarajan JSK, Singh S, Dubala A (2009)
Bioequivalence Study of Simvastatin. J Bioanal Biomed 1: 028-032.
doi:10.4172/1948-593X.1000006 |
Copyright: © 2009 Muralidharan S, et al. This is an open-access article distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author
and source are credited. |
| Abstract |
A simple, rapid and selective method was developed for estimation
of 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 Cmax, AUC0–t and 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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