Determination of Uridine in Human Plasma by HPLC and its Application in Citicoline Sodium Pharmacokinetics and Bioequivalence Studies
- *Corresponding Author:
- Dr. Ruichen Guo
Institute of Clinical Pharmacology
Qilu Hospital of Shandong University
Jinan 250012, P.R. of China.
Tel: (0531) 82169636
Fax: (0531) 86109975
E-mail: [email protected]
Received Date: April 08, 2011; Accepted Date: May 19, 2011; Published Date: May 25, 2011
Citation: Chen K, Liu X, Wei C, Yuan G, Zhang R, et al. (2011) Determination of Uridine in Human Plasma by HPLC and its Application in Citicoline Sodium Pharmacokinetics and Bioequivalence Studies. J Bioequiv Availab 3: 072-076. doi: 10.4172/jbb.1000062
Copyright: © 2011 Chen K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
A simple and rapid high performance liquid chromatography (HPLC) method was developed and validated to determine uridine, metabolite of citicoline, in human plasma, and applied to the pharmacokinetics and bioequivalence studies of citicoline sodium tablet and capsule. Uridine and amoxicillin (used as internal standard, IS) were extracted from plasma by simple protein precipitation with perchloric acid. The separation was performed on a Phenomenex kinetex C18 (100 ×4.6 mm, 2.6μm) column, with a mobile phase of 0.05 M phosphate buffer (Potassium dihydrogen phosphate, adjusted pH to 3.5 by phosphate) - Methanol (98:2, V/V), and delivered at the flow rate of 0.8 mL/min. The calibration curve was linear over uridine concentration range of 0.05-2μg/mL (r>0.99), The main pharmacokinetic parameters of citicoline sodium tablet and capsule were as follows, t 1/2 (4.393±2.526) and (4.857±4.503) h, T max (3.354±1.118) and (3.688±1.082) h, Cmax (1.956±0.402) and (2.070±0.619) μg/mL, AUC0-12 (12.774±3.222) and (13.992±3.953) μg/mL*h, AUC0~∞ (16.015±5.647) and (17.198±6.672) μg/mL*h, respectively. The two-one side t-test analysis showed that the confidential intervals of Cmax, AUC0-12, AUC0~∞ of citicoline sodium tablet and capsule were (89.5%~102.1%), (85.3%~97.5%), (85.3%~102.9%), respectively. The relative bioavailability of citicoline sodium tablets was 92.7%. The tablet and capsule were bioequivalence.