A VALIDATED LC-MS/MS METHOD FOR PHARMACOKINETIC STUDY OF BRIVARACETAM IN HEALTHY RABBITS


D. Atul Vasanth, B. Rajkamal

Abstract


Objective: A liquid chromatography-tandem mass spectrophotometric (LC–MS/MS) method was developed for quantification of brivaracetam in rabit plasma employing liquid-liquid extraction with ethyl acetate.

Methods: Developed method was validated for specificity, precision, accuracy, recovery, and stability characteristics. Chromatographic separation was achieved on Chromolith C18column (100 mmx4.6 mmx5 µm) with 0.1% formic acid, adjusted to pH 3.2 as an isocratic mobile phase with a flow rate of 1.0 ml/min. the developed method was applied to assess pharmacokinetics parameters like Cmax, Tmax, t1/2 and AUC of brivaracetam in healthy rabbits.

Results: The developed method was linear over the range of 0.16 to 8µg/ml. The regression equation for the analysis was Y=0.0053x+0.0018 with coefficient of correction (r2) = 0.998. The % mean recovery for brivaracetam was found to be between 95.7% to 106.5%. The mean intraday and inter-day precision of the method was found to be 0.77 to 3.72% for quality control standards. Brivaracetam showed Tmax of 1.025±0.061 and mean Cmax, AUC0®t andAUC0®a for Test formulation is 92.7±4.4, 496.21±26.4 and 504.20±30.68 respectively.

Conclusion: A highly specific, rugged and rapid method with sufficiently low LLOQ was developed for analysis of routine samples of a single dose or multiple dose pharmacokinetic studies with any marketing formulation of brivaracetam.


Keywords


Brivaracetam, Pharmacokinetics, LC-MS/MS, Rabit model

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About this article

Title

A VALIDATED LC-MS/MS METHOD FOR PHARMACOKINETIC STUDY OF BRIVARACETAM IN HEALTHY RABBITS

Keywords

Brivaracetam, Pharmacokinetics, LC-MS/MS, Rabit model

DOI

10.22159/ijpps.2018v10i2.21457

Date

01-02-2018

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 10, Issue 2, 2018 Page: 24-29

Online ISSN

0975-1491

Authors & Affiliations

D. Atul Vasanth
Mewar University, Chittorgarh, Rajasthan, India
India

B. Rajkamal
Mewar University, Chittorgarh, Rajasthan, India
India


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