摘要
目的 :建立测定麦考酚酸 (MPA)血药浓度的方法并对肾移植病人给药后的血药浓度进行测定。方法 :采用高效液相色谱 (HPLC)法测定血药浓度 ,检测波长 30 3nm。乙腈 (含有 0 .1mol·L- 1磷酸 )作为血样的蛋白沉淀剂。色谱柱 :AgilentXDBC18(15 0mm× 4 .6mm ,5 μm) ;流动相 :乙酸钠缓冲液 (pH =3.0 ,30mmol·L- 1)∶乙腈 =5 7∶4 3(V/V) ;流速 :1mL·min- 1。结果 :MPA血药浓度线性范围为 0 .6～ 30mg·L- 1(r =0 .9995 ,n =6 ) ,其血浆最低检测浓度为 0 .2mg·L- 1;低、中、高 3种浓度MPA的方法回收率为 (98.9± 1.5 ) % ,提取回收率为 (10 6 .73± 0 .2 7) % ;相应 3种浓度MPA的精密度RSD均小于 5 %。结论 :HPLC法能快速、准确对MPA进行血药浓度测定 ,可以用于MPA的临床血药浓度监测和药动学研究。
AIM: To establish a simple and rapid method for determining mycophenolic acid (MPA) in human plasma. METHODS: The plasma concentration was determined by HPLC, and the detector wavelength was set at 303 nm. The plasma sample purification was limited to protein precipitation with acetonitrile (containing 0.1 mol·L -1 phosphoric acid). The sample was separated on an AgilentXDB C 18 column (150 mm×4.6 mm,5 μm),the mobile phase consisted of sodium acetate(30 moL·L -1,pH 3.0) and acetonitrile (57∶43, V/V). The flow rate was 1.0 mL·min -1. RESULTS: The calibration curve of MPA was linear in the range of 0.6-30 mg·L -1(r=0.9995,n=6) in plasma. The limit of detection for MPA was 0.2 mg·L -1. The method recovery rate of low, medium and high concentrations of MPA was (98.9±1.5)%. The extract recovery rate was (106.73±0.27)%. The inter-day RSD of precision was 1.58 %, 0.93 % and 0.65 %. The intra-day RSD of precision was 4.61 %, 1.03 % and 5.66 %. CONCLUSION: HPLC is a simple, rapid, reliable quantitative method for pharmacokinetic study and monitor of MPA.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2004年第5期290-293,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
色谱法
高压液相
麦考酚酸
免疫抑制剂
血药浓度
chromatography, high pressure liquid
mycophenolic acid
immunosuppressive agents
blood drug level
