Abstract:

Objective     To establish a high performance liquid chromatography (HPLC) method for the determination of uridine in human plasma and to evaluate the bioequivalence of CDP-choline capsules and tablets. Methods     Plasma concentrations of uridine were determined after a single oral dose of 600mg CDP-choline capsules and tablets by the established HPLC method with amoxicillin as the internal standard. Main pharmacokinetic parameters of uridine were calculated and bioequivalence of CDP-choline capsules and tablets were evaluated by DAS. Results    The linear regression equation was y=2.10x+0.57(r=0.9928) within a range of 0.05-2μg/mL.The lowest detection limit for uridine was 0.05μg/mL, recoveries were 95.57%-102.09%, and inter-day and intra-day precisions were less than 15%. The concentration of plasma uridine reached a maximum of 3.0μg/mL after 3.5 hours, and then slowly decreased to the base level after 8 hours. 90% confidential intervals of AUC_0-t, AUC_0-∞ and Cmax were 85.3%-97.5%, 85.3%-102.9% and 89.5% -102.1% , respectively. Conclusions    The method is accurate, sensitive and suitable for the determination of uridine in human plasma. CDP-choline tablets and capsules are bioequivalent.

Key words: Chromatography, high performance liquid; Uridine; CDP-choline; Bioequivalence