HPLC测定维生素C注射液有关物质含量

 目的 建立以HPLC测定维生素C注射液中有关物质的含量。方法 采用菲罗门公司NH₂色谱柱(4.6 mm ×250 mm，5 μm)，柱温：45 ℃；以磷酸盐缓冲液(6.8 g磷酸二氢钾用水溶解并稀释至1 000 mL)-乙腈(30∶70)为流动相；流速：1.0 mL·min-1；检测波长：210 nm。结果 该方法定量限为45 ng，破坏出的杂质峰能达到基线分离，抗氧剂不干扰杂质测定。结论 该方法灵敏度高、专属性强、准确，适用于维生素C注射液中有关物质的检测。

Determination of Related Substances in Vitamin C Injection by HPLC

OBJECTIVE To develop a HPLC method for determining the content of related substances in Vitamin C injection. METHODS The sample was analyzed on a NH₂ column (4.6 mm×250 mm，5 μm, Phenomenex) at 45 ℃, with a mobile phase of phosphate buffer (dissolve 6.8 g potassium dihydrogen phosphate in water and dilute to 1 000 mL)-acetonitrile (30∶70), at the detention wavelength of 210 nm and the flow rate was 1.0 mL·min-1. RESULTS The quantitation limit of vitamin C was 45 ng. The peaks of related substances obtained by stress testing were separated thoroughly and antioxidant had no interference with the determination of related substances. CONCLUSION This method was sensitive, special, accurate and suitable for determining the content of related substances in vitamin C injection.