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

D. Atul Vasanth; B. Rajkamal

doi:10.22159/ijpps.2018v10i2.21457

Authors

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

DOI:

https://doi.org/10.22159/ijpps.2018v10i2.21457

Keywords:

Brivaracetam, Pharmacokinetics, LC-MSMS, Rabit model

Abstract

Objective: A liquid chromatography-tandem mass spectrophotometric (LCâ€“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 Âµm) 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, t_1/2 and AUC of brivaracetam in healthy rabbits.

Results: The developed method was linear over the range of 0.16 to 8Âµg/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 T_max of 1.025Â±0.061 and mean C_max, AUC₀_Â®_tandAUC₀_Â®_a for Test formulation is 92.7Â±4.4, 496.21Â±26.4 and 504.20Â±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.

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Author Biographies

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

department of Pharmaceutical Analysis

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

Department of pharmaceutical chemistry

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