HPLC法测定盐酸洛美沙星分散片含量及有关物质

目的:采用高效液相色谱法测定盐酸洛美沙星分散片中洛美沙星的含量及其有关物质.方法:用AichromBond AQ C18(250 mm×4.6 mm,5 μm)色谱柱,流动相:戊烷磺酸钠溶液(取戊烷磺酸钠1.5 g,磷酸二氢铵3.5 g,加水1 000 ml,使溶解,用磷酸调节pH至3.0)-甲醇(63:37);有关物质检测采用梯度洗脱,检测波长:287 nm;柱温:40℃;流速:1.0 ml·min-1.结果:盐酸洛美沙星线性范围为0.022 3～0.223 4 mg·ml-1(r=0.999 9),平均回收率为99.5%(n=9).样品中的杂质均能很好检出,各杂质与主峰之间的分离度良好,定量限为0.81 ng,检测限为0.32 ng.结论:含量测定方法重复性好,准确度高,有关物质检测方法专属性强,适于盐酸洛美沙星分散片的质量控制.

Determination of Lomefloxacin and its Related Substances in Lomeftoxacin Hydrochloride Dispersible Tablets by HPLC

Objective： To establish an HPLC method for the determination of lomefloxacin hydrochloride and its related substances in lomefloxacin hydrochloride dispersible tablets.Method： An AichromBond AQC18 column（250 mm×4.6 mm,5 μm）was used,the mobile phase was sodium pentanesulfonate solution（dissolving 1.5g sodium pentanesulfonate and 3.5g ammonium dihydrogen phosphate in 1 000ml water,then adjusting pH to 3.0 with phosphoric acid）-methanol（63∶ 37）,and the related substances were determined with gradient elution at detection wavelength of 287nm.Result： The linear range of lomefloxacin hydroxide was 0.022 3~0.223 4 mg·ml-1（r=0.999 9）,and the mean recovery was 99.5%（n=9）.Lomefloxacin and its related substances could be well separated.The limit of quantitation was 0.81ng and the limit of detection was 0.32ng.Conclusion： The method is sensitive,accurate and rapid.It is suitable for the quality control of lomefloxacin hydrochloride dispersible tablets.