摘要
目的：建立HPLC法测定注射用环磷腺苷葡胺中葡甲胺的含量。方法：XDB—C18柱（4．6mm×250mm，5wm），流动相为庚烷磺酸钠缓冲液-乙腈（95：5），流量为1．0mL·min-1，检测波长为195nm。结果：葡甲胺在0．25—5mg·mL-1浓度范围内线性回归方程的相关系数为0．9999；平均回收率为100．1％，其RSD为0．42％。结论：本法操作简便，结果准确，可用于注射用环磷腺苷葡胺中葡甲胺的含量测定。
Objective： To establish an HPLC method for determination of Meglumine in Meglumine Adenosine Cyclophosphate for Injection. Methods： The determination was performed on a XDB-C18 column （4. 6 mm × 250 mm,5 μm）with mobile phase of sodium heptanesulfonate buffer solution-aeetonitrile （95：5） . The flow rate was 1.0 mL · min- 1 and the detection wavelength was 195 nm. Results： Meglumine showed a good linearity in the range of 0. 25 -5 mg · mL-1（ r = 0. 999 9） , the average recovery was 100. 1% with RSD of 0. 42%. Conclusion： The method is simple and accurate which could be used to determine Meglumine in Meglumine Adenosine Cyelophosphate for Injection .
出处
《中国药品标准》
CAS
2015年第4期257-260,共4页
Drug Standards of China
