PurposeTo establish a sensitive method for determination of
Zolpidem Tartrate', 1, 1607733)"; href="/tags/zolpidem-tartrate/">zolpidem tartrate concentration in Beagle dogs′ plasma and evaluate the
bioequivalence of zolpidem mouth-dissolving tablets.MethodsPlasma Zolpidem
Tartrate concentration was determined by HPLC-FLD method following a single oral dose 10 mg of two zolpidem tartrate formulations to 6 Beagle dogs in an open randomized crossover test. The pharmacokinetics parameters and relative bioavailability were calculated and the bioequivalence between test tablets and reference standard was evaluated by two-one-side t test.ResultsThe T max of test tablets and reference standard were (26.67±14.72) min and (41.67±18.07) min, C max were (36.416±20.290) ng/ml and (15.100±5.646) ng/ml,
AUC 0-t were (2 890.85±1 101.05) ng·min/ml and (1 388.58±484.11) ng·min/ml, respectively. C max and AUC 0-t of the test tablet were significantly higher than those of the reference. Two one-side t test showed that the two formulations were not bioequivalent.ConclusionThe test formulation was not bioequivalent to the reference preparation and the relative bioavailability was (209.51±37.93)%.
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