HPLC法测定维生素B_(12)滴眼液中的有关物质

目的:建立测定维生素B12滴眼液有关物质的HPLC法。方法:用十八烷基硅烷键合硅胶为填充剂;0.05mol/L磷酸二氢钾-乙腈(86:14),用磷酸调pH值至3.0为流动相;检测波长为361nm。结果:空白辅料对有关物质检查无干扰,主成分峰与杂质峰的分离度符合规定。结论:本方法专属性强、结果准确可靠,可用于维生素B12滴眼液有关物质的测定。

OBJECTIVE: To establish determination of vitamin B12 eye drops related substances by HPLC method.METHODS: Use octadecyl silane bonded silica gel as the filling agent;0.05 mol/L potassium dihydrogen phosphate-acetonitrile(86:14),with phosphoric acid adjustable pH value to 3.0 as mobile phase;Detection wavelength of 361 nm.RESULTS: Blank materials to the related material inspection without interference,principal component peak and impurity peak separation degree in accordance with the provisions.CONCLUSION: This method a strong specificity,results are accurate and reliable,and can be used for vitamin B12 eye drops on the determination of material.