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目的:建立马来酸桂哌齐特注射液含量测定的HPLC方法。方法:色谱柱为Shimpak VP-ODS(250 mm×4.6 mm,5μm),流动相为10 mmol·L~(-1)磷酸二氢钾溶液(磷酸调节pH至4.5)-甲醇(48:52),流速为1.0 ml·min~(-1),检测波长为303 nm,柱温为25℃。结果:马来酸桂哌齐特与内标分离良好,平均回收率为100.0%(RSD 0.21%,n=9),浓度在6.0～84.0 mg·L~(-1)范围内线性关系良好,r=0.999 8。结论:方法简便、灵敏、快速、准确、重复性好,可用于马来酸桂哌齐特注射液的含量测定。
Objective: To establish an HPLC method for the determination of cinepazide maleate injection. METHODS: The chromatographic column was Shimpak VP-ODS (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 10 mmol·L -1 potassium dihydrogen phosphate solution (pH adjusted to 4.5 with phosphoric acid) -methanol (48:52) , The flow rate was 1.0 ml · min -1, the detection wavelength was 303 nm and the column temperature was 25 ℃. RESULTS: Cinepazide maleate was well separated from the internal standard, with an average recovery of 100.0% (RSD 0.21%, n = 9). Good linearity was observed in the range of 6.0 ~ 84.0 mg · L -1. r = 0.999 8. Conclusion: The method is simple, sensitive, rapid, accurate and reproducible. It can be used for the determination of cinepazide maleate injection.