摘要
目的建立高效液相色谱法检查异甜菊醇钠注射剂（STVNa注射剂）中的有关物质。方法采用C18（150 mm×4.6 mm,5μm）色谱柱,以水和乙腈为流动相进行线性梯度洗脱,流速为0.8 m L/min,柱温为40℃,检测波长为210 nm。结果空白溶剂及空白辅料均不干扰检测,本方法可将异甜菊醇（ISV）粗品和STVNa注射剂经破坏性试验所得样品中的杂质进行有效分离;重复性考察的RSD值为13%;在0.003~1 mg/m L质量浓度范围内与峰面积响应值呈良好的线性关系,相关系数为0.999 6。结论本方法专属性强、重复性好,可用于STVNa注射剂中有关物质的检查。
Objective To establish an HPLC method for the determination of impurities in isosteviol sodium（ STVNa） injection. Methods The separation was performed on C18（ 150 mm× 4.6 mm,5 μm） column eluted with a linear gradient mobile phase of water and acetonitrile. The flow rate was 0. 8 m L / min and column temperature was 40 ℃. The detection wavelength was set at 210 nm. Results Blank solvents and accessories caused no interference. The impurities were separated well in crude ISV samples and destructive testing of STVNa injection. RSD was 13% in the repeatability experiments. The calibration curve was linear within the range of 0.003-1 mg / m L,and the correlation coefficient was 0.999 6. Conclusion This method is specific and reproducible for the determination of impurities in STVNa injection.
出处
《广东药学院学报》
CAS
2015年第5期598-601,共4页
Academic Journal of Guangdong College of Pharmacy
基金
东莞松山湖创新生物医药产业集群建设项目(2012B011000050)
