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目的:建立测定注射用降纤酶中降纤酶的高效液相色谱分析方法。方法:色谱柱为Vydac 214TP54-C4(5μm,250 mm×4.6 mm),流动相A为0.1%三氟乙酸,B为乙腈-水(90:10,含0.1%三氟乙酸),流速为0.8 mL.min-1,采用梯度洗脱,柱温45℃,检测波长为280 nm。结果:降纤酶在0.5～32μg.mL-1(r=0.9999)范围内线性关系良好,平均回收率(n=9)为98.5%。结论:该法快速、灵敏、准确,可以为注射用降纤酶的质量控制提供依据。
Objective: To establish a method for the determination of defibrase in injectable defibrase by high performance liquid chromatography. Methods: The chromatographic column was Vydac 214TP54-C4 (5 μm, 250 mm × 4.6 mm). The mobile phase A was 0.1% trifluoroacetic acid and B was acetonitrile-water (90:10 with 0.1% trifluoroacetic acid) mL.min-1, using a gradient elution, the column temperature 45 ℃, the detection wavelength was 280 nm. Results: The defibrase showed a good linearity in the range of 0.5 ~ 32μg.mL-1 (r = 0.9999) with an average recovery of 98.5% (n = 9). Conclusion: The method is rapid, sensitive and accurate and can provide the basis for the quality control of defibrase for injection.