Bioequivalence study of 10 mg zaleplon tablets in Egyptian healthy volunteers

ABSTRACT

Development of a simple, rapid and routine assay of zaleplon [ZL] in plasma for the investigation of Zaleplon [ZL] pharmacokinetic parameters in human and to compare the bioequivalence parameters of 10 mg [ZL] tablets manufactured locally [Test] with originally [Reference]. The drug, after extraction from plasma, was chromatographic on a C-18 reversed- phase column and detected at 232 nm, the mobile phase consisted of 0.1M potassium dihydrogen phosphate acetonitrile [3565] V/V pH 4 adjusted with 5% orthophosphoric acid at a flow rate of 1 ml/min. The bioequivalence study was performed according to a randomized, single dose, two-treatment, two-period, two-sequence crossover study conducted on twenty-four healthy volunteers. The criteria used to assess bioequivalence of the two products were t max, C max, k ab, t ab, k 1/2el, t1/2el, AUC 0-12, and AUC 0-00. The described method for analysis showed that the recovery of ZL from plasma was 99.63% with a coefficient of variation of 0.321. Moreover, the 90% confidence intervals for the mean ratio [test/reference] of C max, AUC 0-12, and AUC 0-00 were within the acceptance range [80%-125%]. The HPLC method presented is direct, simple, reproducible, sensitive and linear for the determination of ZL in human plasma and is adequate for its clinical pharmacokinetic studies, besides, the Test was found to be bioequivalent to the Reference and both products can be considered interchangeable in medical practice