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| 摘要: |
| 目的 建立反相高效液相色谱法，同时测定人血浆中霉酚酸(mycophenolic acid, MPA)、酚化葡萄糖醛麦考酚酸(phenol glucuronide metabolite, MPAG)、酰基化MPAG(acyl-MPAG, AcMPAG)的浓度。方法 用蛋白沉淀法对样品进行处理。固定相为Zorbax Eclipse XDB C18柱(4.6 mm×250 mm，5 mm)，流动相：甲醇: 20 mmol×L-1 NaH2PO4(用20%磷酸调至pH 3.0)为55∶45，流速：1.2 mL×min-1，检测波长：304 nm，柱温：45 ℃。结果 MPA、MPAG、AcMPAG浓度在0.2~50 mg×mL-1(r=0.999 7)、2.8~531 mg×mL-1(r=0.999 9)、0.3~24 mg×mL-1( r=0.999 4)内呈良好的线性关系。MPA及其代谢物的绝对回收率均大于80%，MPA、MPAG、AcMPAG的相对回收率分别为94.0%~101.4%，98.4%~101.9%和96.1%~104.2%。日内及日间RSD远低于15%。结论 采用反相高效液相色谱法测定人血浆中MPA、MPAG、AcMPAG的浓度和进行药物代谢动力学研究，方法灵敏度高、重复性强 |
| 关键词: 霉酚酸 酚化葡萄糖醛麦考酚酸 酰基化MPAG 反相高效液相色谱法 血浆浓度 |
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| Determination of Mycophenolic Acid and its Metabolins in Human Plasma by RP-HPLC |
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ZHAO Qiang1 2 GAO Feng3
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| Abstract: |
| OBJECTIVE RP-HPLC method detection for simultaneous determination of Mycophenolic acid (MPA), its phenol glucuronide metabolite (MPAG) and acyl-MPAG (AcMPAG) in human plasma was established. METHODS The plasma samples were prepared with protein-precipitating reagent, and the supernatant was eluted on Zorbax column (250 mm×4.6 mm, 5 mm) with 20 mmol×L-1 NaH2PO4 buffer (pH 3.0, adjusted with 20% phosphoric acid) and methanol (45∶55) at 304 nm. The column temperature was 45 ℃, and the flow rate was 1.2 mL×min-1. RESULTS The assay was linear within the range of 0.2-50 mg×mL-1 for MPA (r=0.999 7), 2.8-531 mg×mL-1 for MPAG(r=0.999 9), and 0.3-24 mg×mL-1 for AcMPAG(r=0.999 4). Mean absolute recovery of MPA and its metabolites was more than 80%. The average recoveries of MPA, MPAG and AcMPAG were 94%.0–101.4%, 98.4%–101.9% and 96.1%–104.2 %, respectively. The RSD of within-day and between-day were all lower than 15%. CONCLUSION The method described is sensitive, reproducible, and will be useful in TDM or pharmacokinetic studies of MPA. |
| Key words: mycophenolic acid phenolic glucuronide of mycophenolic acid acyl-MPAG RP-HPLC plasma concentration |
