TY - JOUR AU - Zhang, Wei; Xiang, Bing-ren; Zhang, Jing TI - High-performance Liquid Chromatography Method for the Determination of Mycophenolic Acid in Human Plasma and Application to a Pharmacokinetic Study of Mycophenolic Acid Dispersible Tablet SN - 0004-4172 SN - 1616-7066 PY - 2008 JO - Arzneimittelforschung JF - Arzneimittelforschung LA - EN VL - 58 IS - 07 SP - 348 EP - 352 DA - 2011/12/15 KW - CAS 24280-93-1 KW - Immunosuppressants KW - Mycophenolic acid, determination in human plasma, HPLC-UV, pharmacokinetics AB - A sensitive and selective high-performance liquid chromatographic-ultraviolet (HPLC-UV) method for the determination of mycophenolic acid (MPA, CAS 24280-93-1) in human plasma has been developed. Sample treatment was based on protein precipitation with a trichloroacetic acid-water (10:90, w/v) solution. The analytical determination was carried out by HPLC with ultraviolet detection at 254 nm. Chromatographic separation was achieved on a C18 column by isocratic elution with acetonitrile-water (pH 4.4) (50:50, v/v) at a flow rate of 1.0 mL/min. The method was linear in the concentration range of 0.2–50.0 μg/mL. The lower limit of quantification (LLOQ) was 0.2 μg/mL. The intra-day and inter-day relative standard deviations across three validation runs over the entire concentration range were less than 7.05%. The accuracy determined at three concentrations (0.4, 5.0 and 20.0 μg/mL for MPA) was within ± 10.0%. The method was successfully applied to the evaluation of the pharmacokinetic profile of MPA dispersible tablet in 20 healthy volunteers. The results showed that AUC, Cmax and T1/2 for the test and reference formulations were not significantly different (P > 0.05). The relative bioavailability was 96.42 ± 15.5%. PB - Editio Cantor Verlag DO - 10.1055/s-0031-1296518 UR - http://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0031-1296518 ER -