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目的:建立采用高效液相色谱法测定去甲斑蝥素原料药的含量。方法:色谱柱为C_(18)(250mm×4.6mm,5μm),流动相为甲醇-0.016mol·L~(-1)磷酸二氢钾溶液(17:83)(用磷酸调pH至3.1),检测波长为210nm。结果:去甲斑蝥素能与杂质有较好的分离,在4～60μg·ml~(-1)范围内线性关系良好(r=0.999 9);平均加样回收率为99.62%(RSD=1.85%)。结论:方法简单,结果准确,重复性好,适用该产品的含量测定。
Objective: To establish a HPLC method for the determination of norcantharidin drug substance content. Methods: The chromatographic column was C 18 (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-0.016 mol·L -1 potassium dihydrogen phosphate solution (17:83) (adjusted to pH 3.1 with phosphoric acid) , Detection wavelength of 210nm. Results: Norcantharidin was able to be separated from impurities with good linearity in the range of 4 ~ 60μg · ml -1 (r = 0.999 9). The average recovery was 99.62% (RSD = 1.85 %). Conclusion: The method is simple, the result is accurate and the repeatability is good. The determination of the content of the product is suitable.