Gabapentin Bioequivalence Study: Quantification by Liquid Chromatography Coupled to Mass Spectrometry

Eduardo Abib Junior, Luciana Fernandes Duarte, Renata Pereira
2011 Journal of Bioequivalence & Bioavailability  
The study was performed to compare the bioavailability of two gabapentin 400 mg capsule formulation (Gabapentin from Arrow Farmacêutica S/A as test formulation and Neurontin ® from Pfizer, Brazil, as reference formulation) in 26 volunteers of both sexes. The study was conducted open with randomized two period crossover design and a one week wash out period. Plasma samples were obtained over a 48 hour interval. The gabapentin was analyzed by LC/MS/MS, in the presence of pracetamole as internal
more » ... andard. With plasma concentration vs. time curves, data obtained from this metabolite, the following pharmacokinetics parameters were obtained: AUC 0-t , AUC 0-inf and C max . Geometric mean of gabapentin/Neurontin ® 400 mg individual percent ratio was 100.58% AUC 0-t , 101.35% for AUC 0-inf and 97.76% for C max . The 90% confidence intervals were 92.00 -109.95%, 93.00 -110.44%, 88.41 -108.10%, respectively. Since the 90% confidence intervals for C max , AUC 0-t and AUC 0 -inf were within the 80 -125% interval proposed by Food and Drug Administration, it was concluded that gabapentin 400 mg capsule was bioequivalent to Neurontin ® 400 mg capsule according to both the rate and extent of absorption. Volume 3(8): 187-190 (2011) -188 J Bioequiv Availab ISSN:0975-0851 JBB, an open access journal Citation: Junior EA, Duarte LF, Pereira R, Pozzebon JM, Tosetti D, et al. (2011) Gabapentin Bioequivalence Study: Quantification by Liquid Chromatography Coupled to Mass Spectrometry.
doi:10.4172/jbb.1000083 fatcat:ooic3qszyvezvkqbi5bq2ztta4