Abstract Purpose: To establish a rapid and sensitive high-performance liquid chromatographic method for determination of sodium ozagrel in human plasma and urine and investigate the pharmacokinetics of sodium ozagrel oral solution in healthy volunteers. Methods: Following solid-extraction of the drug and an internal standard (caffein), chromatographic separation was accomplished using a C18 analytical column with a mobile phase consisting of sodium phosphate buffer (0.05 mol/l, pH 3.0) and acetonitrile (94:6 for plasma and 96:4 for urine, v/v). Sodium ozagrel and the internal standard were detected by ultraviolet absorbance at 276 nm. A pharmacokinetic study was performed in 12 healthy volunteers after oral administration of sodium ozagrel oral solution containing 200 mg sodium sodium ozagrel. Results: The average extraction recoveries of the drug from plasma and urine were 92.5% and 95.1%, respectively. The lower limits of detection and quantification were both 2 and 10 ng/ml, respectively, and the calibration curves were linear over a concentration range of 0.01–10 μg/ml of sodium ozagrel in human plasma and urine. The pharmacokinetics of sodium ozagrel oral solution was investigated in volunteers and the plasma concentration-time data were fitted to a two-compartment model. Conclusion: The method provides a sensitive, accurate and reliable analytical procedure suitable for pharmacokinetic studies of sodium ozagrel.
Kaoxiang Sun,
Rongcai Liang,
Aiping Wang etc
.Determination of sodium ozagrel in human plasma and urine by HPLC with solid-phase extraction and its application to pharmacokinetics[J] AJPS, 2006,V1(3-4): 222-228