Comparative bioavailability of two zolpidem hemitartrate formulations in healthy human Brazilian volunteers using high-performance liquid chromatography coupled to tandem mass spectrometry.

Comparative bioavailability of two zolpidem hemitartrate formulations in healthy human Brazilian volunteers using high-performance liquid chromatography coupled to tandem mass spectrometry. Biomed Chromatogr. 2019 Oct 25;:e4731 Authors: Mendes GD, Pereira TDS, Rodrigues JC, Santos EM, Souza MR, Lopes-Martins RAB, Antunes NJ, Moreno RA, De Nucci G Abstract To assess the bioequivalence of two zolpidem hemitartrate formulations in 30 healthy volunteers. Plasma samples were obtained over a 24h period. Plasma concentrations of zolpidem were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring. Cmax, ASC, T1/2, Ke, Vd and Cl showed statistically significant differences when comparing women (604.34 ng*h/mL, 127.36 ng/mL, 4.4h, 0.18 1/h, 50.56 L, 8.55 L/h) and men (276.1ng*h/mL, 70.9 ng/mL, 3.3h, 0.26 1/h, 91.42 L, 24.34 L/h), receiving the same dose (5mg), respectively. The geometric mean with corresponding 90% confidence interval for Test/Reference percent ratios were 99.73% (CI 93.69-106.16) for Cmax, 97.44% (90% CI= 91.85-103.37%) for AUClast and 98.30% (90% CI= 92.48-104.49) for AUCinf . Since the 90% CI for AUClast , AUCinf and Cmax ratios were within the 80-125% interval proposed by the US FDA, it was concluded that zolpidem hemitartrate formulation (5 mg orodispersible tablet) is bioequivalent to the zolpidem hemitartrate formulat...
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Tags: Biomed Chromatogr Source Type: research