反相高效液相色谱法测定盐酸克林沙星片中克林沙星的含量

Determination of clinafloxacin in clinafloxacin hydrochloride tablets by RP-HPLC

目的 建立盐酸克林沙星片中克林沙星含量的测定方法。方法 反相高效液相色谱法。色谱柱为ALLTIMAC185 μ( 4 .6mm× 2 5 0 ) ,流动相为 [0 .0 5mol/L枸橼酸 1mol/L醋酸铵 ( 77∶1) ,三乙胺调 pH =4 .0 ] 乙腈 ( 82∶18) ,检测波长为2 97nm。结果 平均回收率为 99.36 % ,RSD为 0 .4 5 % (n =9)。日内精密度为 0 .2 2 % (n =3) ,日间精密度为 0 .2 8% (n =3)。结论 反相高效液相色谱法测定盐酸克林沙星片中克林沙星的含量准确、灵敏、专属性强。

OBJECTIVE To develop the method for determination of clinafloxacin in clinafloxacin hydrochloride tablets. METHOD The determination was performed by RP HPLC with the ALLTIMA column(4.6mm×250mm, 5μm), the mobile phase was pH4.0 buffer solution[0.05mol/L citric acid:1mol/L amaonium acete(77∶1), adjusted the solution with triethylamine to pH4.0] acetonitrile(82∶18), the UV detector was set at 297nm.RESULTS The average recovery was 99.36% with the RSD=0.45%( n =9). The intra day and inter day precisions were 0.22%( n =3) and 0.28%( n =3), respectively.CONCLUSION The method is accurate,sensitive and specific.