Determination of Plasma Concentration of Mycophenolic Acid in Renal Transplantation Patients by HPLC-fluoremetry / 中国药师

ABSTRACT

Objective: To establish an HPLC-fluoremetry method for determination of the plasma concentration of mycophenolic acid ( MPA) in renal transplantation patients. Methods:The sample was subjected to precipitate proteins using acetonitrile, and the supernatant (20 μl) was used for the sample injection and determination on a Hypersil BDS C18 (250 mm × 4. 6 mm, 5 μm) column with temperature at 25℃. The mobile phase consisted of acetonitrile-methanol-0. 2 mol·L-1 dipotassium hydrogen phosphate buffer (pH=9. 0)( 18∶2∶80)with the flow rate of 1. 0 ml·min-1. The excitation wavelength (Ex) was 342 nm and the emission wave-length ( Em) was 425 nm. Results:The endogenous plasma impurities and drug combinations had no interference with the determina-tion. The calibration curve was linear over the range of 0. 25-50. 00 mg·L-1(r=0. 999 7), and the lower limit of quantification was 0. 25 mg·L-1 . The mean methodological recovery was 99. 12% and the mean extraction recovery was 93. 27%, the intra-day RSD was less than 2% and the inter-day RSD was less than 6%. Totally 10 cases of renal transplantation patients were with mycophenolate mofetil at the dose of 0. 5-1. 75 g·d-1 , and MPA in plasma was within the range of 0. 43-21. 58 mg·L-1 . Conclusion:The method is rapid, sensitive, accurate and convenient, which can be used in the quantitative determination of plasma concentration of MPA in re-nal transplantation patients.