Objective: To es tablish an HPLC method for determining mizoribine in human serum for clinical individualized medicine. Methods: After precipitation of serum proteins with 10% perchloric acid, mizoribine was determined by HPLC on a reversed phase Megres C18 column (4.6 mm×250 mm, 5μm). The mobile phase was a mixture of methanol and 40 mmol·L-1 phosphate buffer adjusted to pH 3.5, in the ratio of 2∶98 and delivered at a flow rate of 0.9 mL·min-1. The UV detection was set at 280 nm. Results: The peak area for mizoribine was linearly related to its concentrations, which ranged from 0.05 to 10μg·mL-1 (r=0.9998). The intra- and inter-day relative standard deviation values were within 7.9%, the extraction recoveries were over 95.3%. The samples, unprocessed, processed, in store or after 3 cycles of freeze and thaw processes, were stable. Conclusions: The established HPLC method is fast, sensitive, and accurate. It could be applied to therapeutic drug monitoring.%目的：建立人血清中咪唑立宾（MZR）的高效液相色谱测定方法，为临床MZR的个体化用药提供方法学参考。方法：采用10%高氯酸直接沉淀血清蛋白，色谱柱为Megres C18（4.6 mm ×250 mm，5μm），流动相为甲醇-40 mmol·L-1磷酸盐缓冲液（pH=3.5，2∶98，v/v），流速为0.9 mL· min-1，检测波长为280 nm。结果：MZR在0.05~10μg·mL-1范围内线性关系良好（r=0.9998），批内、批间准确度偏差小于4.6%，批内、批间精密度RSD＜7.9%，在室温放置、冰冻、反复冻融条件下考察样品稳定性，MZR均保持稳定，偏差小于4.9%。结论：高效液相色谱法测定MZR血药浓度的方法快速、准确、灵敏度高，适合在治疗药物监测中常规应用。
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