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目的:建立RP-HPLC法测定维生素C粉针剂中维生素C和有关物质的含量。方法:采用的色谱柱为Phenomenex luna氨基柱(5μm,4.6mm×250mm),柱温25℃,流动相为0.02mol.L-1的磷酸二氢钾液(pH=3.0)和乙腈的混合液(体积比1∶1),系统流速1.0mL.min-1,检测波长为245nm。结果:该方法的线性范围为5.0~30.0μg.mL-1,标准曲线的相关系数为0.999 5;日内和日间精密度的RSD分别小于0.53%、2.98%;平均加样回收率(n=9)为99.12%,RSD=2.44%。结论:此法灵敏度高,结果准确,重现性好,可有效控制维生素C粉针剂的质量。
Objective: To establish an RP-HPLC method for the determination of Vitamin C and related substances in vitamin C powder injection. Methods: The chromatographic column was Phenomenex luna (5μm, 4.6mm × 250mm). The column temperature was 25 ℃ and the mobile phase was 0.02mol. The mixed solution of L-1 potassium dihydrogen phosphate (pH = 3.0) and acetonitrile (Volume ratio 1: 1), the system flow rate 1.0mL.min-1, detection wavelength of 245nm. Results: The linear range of this method was 5.0 ~ 30.0μg.mL-1, the correlation coefficient of standard curve was 0.999 5. The RSD of intra-day and inter-day precision was less than 0.53% and 2.98%, respectively. The average recovery was n = 9) was 99.12%, RSD = 2.44%. Conclusion: This method has high sensitivity, accurate results and good reproducibility, which can effectively control the quality of Vitamin C powder injection.