摘要
目的:建立用高效液相色谱法测定注射用加替沙星中有关物质的方法。方法:色谱柱为C18柱(250mm×4.6mm,5μm),流动相为0.1%磷酸溶液-乙腈(87∶15),流速为1.0mL/min,柱温为30℃,检测波长为293nm。结果:加替沙星线性浓度范围是2.5～160.0μg/mL(r=0.9996),各项专属性试验中加替沙星主峰与其他杂质峰基线均分离良好,有关物质的检测限为5ng(S/N>3),3批样品中主要杂质峰面积之和均未超过主峰面积的1%。结论:该方法简便,结果准确、稳定。
Objective： To establish HPLC method fi）r determination of the related substances in gatifloxacin for injection. Methods： The determination was performed with C18（250 mm×4.6mm,5μm） as the chromatographic colunm. T he mobile phase was consisted of 0. 1% phosphoric acid-acetonitrile （87：15） with a flow rate at 1.0 mL/min. The column temperature was 30℃ and the detection wavelength was 293 nm. Results： Good linear relation was achieved when the gatifloxaein concentration was at the range of 2.5 - 160.0μg/mL （ r = 0. 999 6）. All the chief peaks of gatifloxacin and those of their related substances were well isolated in all the specificity tests, and the detective limit was 5 ng（S/N〉3）. The total peak area of the chief related substances of all 3 batches of samples was not more than 1% of the chief peak area of their solutions. Conclusion： This method is simple, accurate and stable.
出处
《中国药业》
CAS
2006年第3期31-32,共2页
China Pharmaceuticals
