摘要
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,5μm),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1000 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。
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 colunm （4. 6 mm × 250 mm,5μm, 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 thorougbly 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.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2010年第24期1948-1950,共3页
Chinese Pharmaceutical Journal
