alexa Determination of Amtolmetin and Its Active Metabolites
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Research Article

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: [email protected]

Received Date: February 02, 2010; Accepted Date: March 23, 2010; Published Date: March 23, 2010

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 so dium and tolmetin glycinamide from human plasma. The method in- volves extracting amtolmetin guacil, tolmetin sodiu m and tolmetin glycinamide with acetonitrile using coumar in as internal standard. Chromatographic separation was c arried out on a C8 column using mixture of acetonitrile:me thanol: 1% acetic acid as mobile phase with UV detection se t 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 μ g/ml for amtolmetin guacil, tolmetin sodium and tolmetin glycinamide. The co-efficient o f varia- tion for intra-day and inter-day accuracy and preci sion was <8.2 % for amtolmetin guacil, tolmetin sodium and t olmetin glycinamide. An open, randomized, two-treatment, tw o pe- riod, single dose crossover, bioequivalence study i n twelve fasting, healthy, male, volunteers was conducted. A fter dos- ing, serial blood samples were collected for the pe riod of 24 h. Various pharmacokinetic parameters for both the active metabolites (tolmetin and tolmetin glycinamide) wer e de- termined from plasma concentration of both formulat ions. Log transformed values were compared by analysis of vari- ance (ANOVA) followed by classical 90% confidence i n- terval for C max , AUC 0-t and AUC 0-inf for both the active me- tabolites (tolmetin and tolmetin glycinamide) and i t 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 i n a bioequivalence study of amtolmetin guacil tablet.

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