| Research Article |
Open Access |
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| Determination of Amtolmetin and Its Active Metabolites
in Plasma by HPLC-UV: Application to a Bioequivalence Study |
| Punnamchand Loya1 and Madhusudan N. Saraf2* |
| 1Ph.D (T) research scholar, The Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai-400 098 |
| 2Principal & Professor of Pharmacolgy, The Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai-400 098 |
| *Corresponding author: |
Madhusudan N. Saraf,
Principal & Professor of
Pharmacolgy,
The Bombay College of Pharmacy,
Kalina, Santacruz (E),
Mumbai-400 098,
E-mail: pcloya@gmail.com |
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| Received February 02, 2010; Accepted March 23, 2010; Published March
23, 2010 |
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| Citation:Loya P, Saraf MN (2010) Determination of Amtolmetin and Its Active
Metabolites in Plasma by HPLC-UV: Application to a Bioequivalence
Study. J Bioequiv Availab 2: 037-044. doi: 10.4172/jbb.1000028 |
| |
| Copyright: © 2010 Loya P, 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
the determination of amtolmetin guacil, tolmetin sodium and
tolmetin glycinamide from human plasma. The method involves
extracting amtolmetin guacil, tolmetin sodium and
tolmetin glycinamide with acetonitrile using coumarin as
internal standard. Chromatographic separation was carried
out on a C8 column using mixture of acetonitrile:methanol:
1% acetic acid as mobile phase with UV detection set at
313 nm. The retention time of AG, T, TG and IS were
8.20±0.2, 5.3±0.2, 4.0±0.2 and 4.9±0.2 min, respectively.
The method was validated and found to be linear in the
range of 0.5-20.0 μg/ml for amtolmetin guacil, tolmetin
sodium and tolmetin glycinamide. The co-efficient of variation
for intra-day and inter-day accuracy and precision was
<8.2 % for amtolmetin guacil, tolmetin sodium and tolmetin
glycinamide. An open, randomized, two-treatment, two period,
single dose crossover, bioequivalence study in twelve
fasting, healthy, male, volunteers was conducted. After dosing,
serial blood samples were collected for the period of 24
h. Various pharmacokinetic parameters for both the active
metabolites (tolmetin and tolmetin glycinamide) 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-inf for both the active metabolites
(tolmetin and tolmetin glycinamide) and it was
found that both test and reference products were
bioequivalent. The proposed method proved to be rapid,
precise and accurate and can be successfully used in a
bioequivalence study of amtolmetin guacil tablet. |
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