ملخص البحث
A new and simple HPLC assay method was developed and validated for the determination of eta msylate in human plasma. After protein precipitation with 6% perchloric acid, satisfactory se paration was achieved on a HyPURITY C18 column (250 mm X 4.6 mm, 5μm) using a mobile phase co mprised 20 mM sodium dihydrogen phosphate-2 hydrate (pH was adjusted to 3.5 by phosphoric ac id) and acetonitrile at a ratio of 95:5 v/v. The elution was isocratic at ambient temperature with a flo w rate of 0.75 ml/min. Allopurinol was used as internal standard. The calibration curve was linear over the range from 0.25 to 20 μg/ml (r 12 2= 0.999). The limit of quantification for etamsylate in plasma
wa s 0.25 μg/ml. The day-to-day coefficient of variance (%CV) ranged from 3.9% to 10.2 %, whereas th e between-days %CV ranged from 3.1% to 8.7%. The assay method has been successfully used to
estimate the pharmacokinetics of etamsylate after oral administration of a 500 mg tablet under fasting co nditions to 24 healthy Egyptian human male volunteers. Various pharmacokinetic parameters
including AUC0–t, AUC0–∞ , Cmax, Tmax, t1/2, MRT, Cl/F, and Vd/F were determined from plasma co ncentration-time profile of etamsylate.