RP-HPLC法测定盐酸洛美沙星分散片的含量

目的建立盐酸洛美沙星分散片的含量测定方法。方法采用高效液相色谱法,菲罗门Gemini-C18柱(250mm×4.6mm,5μm);流动相:戊烷磺酸钠溶液(取戊烷磺酸钠1.5g,磷酸二氢铵3.5g,加水950mL使溶解,用磷酸调节pH值至3.0,用水稀释至1 000mL)-甲醇(65∶35);检测波长:287nm。结果洛美沙星质量浓度在10.0～199.5μg.mL-1范围内与峰面积线性关系良好(r=1.000 0),平均回收率为100.4%,RSD为0.3%(n=9)。结论该方法简便、准确、重复性好,可用于盐酸洛美沙星分散片的质量控制。

Determination of the content of Dispersoid Lomefloxacin Hydrochloride Tablets by RP-HPLC

Objective To establish an RP-HPLC method for determining the content of Dispersoid Lomefloxacin Hydrochloride Tablets.Methods HPLC analysis was carried out on a Phenomenex Gemini-C18 column（250 mm×4.6 mm,5 μm）,and pentanesulfonate sodium salt solution（consisting of 1.5 g pentanesulfonate sodium salt,3.5 g ammonium dihydrogen phosphate,and 950 mL water,adjusting pH to 3.0 with phosphate,and adding water 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 and the areas in the range of 10.0~199.5 μg·mL-1（r=1.000）,and the mean recovery was 100.4% with RSD 0.3%（n=9）.Conclusion The method is simple,accurate and reproducible.It is suitable for the quality control of Dispersoid Lomefloxacin Hydrochloride Tablets.