篇名: HPLC法测定妥舒沙星环合物中的有关物质
摘要: 目的:建立测定妥舒沙星环合物中有关物质的方法。方法:采用高效液相色谱法。色谱柱为YMC-Pack ODS A-312,流动相为乙腈-水(5 ∶ 3,V/V),流速为1.2 ml/min,检测波长为250 nm,柱温为25 ℃,进样量为10 μl。结果:该色谱条件能将妥舒沙星环合物中主成分与有关物质基线分离;妥舒沙星环合物检测质量浓度线性范围为0.04~1.8 μg/ml(r=0.999 9);妥舒沙星环合物定量限为40.56 ng/ml,检测限为6.3 ng/ml;精密度、稳定性、重复性试验的RSD<3%;回收率为99.88%~100.68%(RSD=0.29%,n=9);6批样品总杂质含量测定结果均<0.1%。结论:该方法专属性强,灵敏度、准确度和精密度高,可用于妥舒沙星环合物中有关物质的测定。
ABSTRACT: OBJECTIVE: To establish a method for the determination of related substances in tosufloxacin cyclizaton. METHODS: HPLC was performed on the column of YMC-Pack ODS A-312 with mobile phase of acetonitrile-water(5 ∶ 3,V/V) at a flow rate 1.2 ml/min, detection wavelength was 250 nm, column temperature was 25℃ and injection volume was 10 μl. RESULTS: The main component and related substances could be baseline separated by the conditions; the linear range was 0.04-1.8 μg/ml (r=0.999 9);the limit of quantification was 40.56 ng/ml and the limit of detection was 6.3 ng/ml; RSDs of precision, stability and reproducibility tests were lower than 3%; recovery was 99.88%-100.68%(RSD=0.29%,n=9); the result of total impurities of 6 batches of sample were less than 0.1%. CONCLUSIONS: The method is specific, sensitivity with high accuracy and precision, and can be used for the determination of related substances in tosufloxacin cyclizaton.
期刊: 2016年第27卷第33期
作者: 章激
关键字: 妥舒沙星环合物;高效液相色谱法;有关物质
KEYWORDS: Tosufloxacin cyclizaton; HPLC; Related substance
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