反相高效液相色谱法测定盐酸洛美沙星氯化钠注射液中洛美沙星的含量

Determination of lomefloxacin in lomefloxacin hydrochloride and sodium chloride injection by RP-HPLC

目的:建立盐酸洛美沙星氯化钠注射液中洛美沙星含量的测定方法。方法:高效液相色谱法,色谱柱菲罗门Gemini-C18(250 mm×4.6 mm,5μm),流动相:以戊烷磺酸钠溶液(取戊烷磺酸钠1.5 g,磷酸二氢铵3.5 g,加水950 ml使溶解,用磷酸调节pH值至3.0,用水稀释至1 000 ml)-甲醇(65∶35)为流动相,检测波长为287 nm。结果:在10.0～199.5μg/ml范围内,洛美沙星色谱峰峰面积与其浓度成良好线性关系(r=1.000 0),平均回收率为100.11%,RSD为0.51%(n=9)。结论:本方法简便、准确、重现性好,可用于盐酸洛美沙星氯化钠注射液的质量控制。

Objective：To establish a RP-HPLC method for determination the content of lomefloxacin in lomefloxacin hydrochloride and Sodium Chloride Injection.Methods：HPLC analysis was carried out with a Phenomenex Gemini-C18 column（250 mm×4.6 mm,5 μm） and Sodium Pentanesulfonate solution（consisting of Sodium pentanesulfonate 1.5 g,ammonium dihydrogen phosphate 3.5 g,Pure water add 950 ml,adjust pH to 3.0 with phosphoric acid,water add to 1 000 ml）-methanol（65∶35） as the mobile phase.The detection wavelength was 287 nm.Results：There was a good linear relationship between the concentration of lomefloxacin hydrochloride and the areas in the range of 10.0～199.5 μg/ml（r=1.000）,the mean recovery was 100.1% with RSD 0.5%（n=9）.Conclusion：The method is sensitive,accurate and rapid.It is suitable for quality control of lomefloxacin hydrochloride and sodium chloride injection.