中国医药科学Issue(18)：116-117,120,3.
HPLC法测定盐酸莫西沙星葡萄糖注射液中有关物质的含量
Related substances study in moxifloxacin hydrochloride and glucose injection
苏敏 1章志强 2谭亚亚 3章武强 4马东卫1
作者信息
- 1. 陕西方舟制药有限公司，陕西西安710075
- 2. 陕西省体育科学研究所，陕西西安710025
- 3. 西安正大制药有限公司，陕西西安710051
- 4. 江西省儿童医院，江西南昌330006
- 折叠
摘要
Abstract
Objective To establish the determination method of the related substances in moxifloxacin hydrochloride and glucose injection. Methods High performance liquid chromatography(HPLC) was used for the determination of the known impurity A, B,C,D,E and the unknown impurities.The analysysis was performed on a BDS HYPERSIL C18 column(4.6mm×250mm,5μm).The mobile phase was composed of methanol(0.50g/L tetrabutylammonium hydrogen sulfate,1.0g/L monopotassium phosphate and 3.4g/L Posphoric acid mixed solution,28 ∶ 72).With the flow of 1.5mL/min.The detetection wavelength was 293nm. Results The chromatographic peak area and concentration of Moxacin hydrochloride showed a good linear relationship(r=0.9992),at the range of 0.1259-5.036μg/mL. The degree of precision:RSD was 0.78%.The detection limit and quantitation limit for moxacin hydrochloride were 0.74ng and 2.53ng.The stability of solution:test solution and contrast solution was stable in 8 hours. Conclusion This method is convenient,a good specificity,high sensitivity.It can be used for the determination of related substance of moxacin hydrochloride.关键词
盐酸莫西沙星/葡萄糖注射液/HPLC法Key words
Moxifloxacin hydrochloride/Glucose injection/High performance liquid chromatography分类
医药卫生引用本文复制引用
苏敏,章志强,谭亚亚,章武强,马东卫..HPLC法测定盐酸莫西沙星葡萄糖注射液中有关物质的含量[J].中国医药科学,2013,(18):116-117,120,3.
