盐酸环丙沙星栓的高效液相色谱法测定及体外溶出度考察

The determination by HPLC and dissolution of ciporfloxacin hydrochloride suppository

目的 :建立HPLC测定盐酸环丙沙星栓含量的方法 ,并对体外溶出度考察。方法 :以Ultrasphere ODS柱 ,流动相为甲醇 乙腈 0 .1mol·L-1磷酸二氢钾 (5∶4∶9) ,检测波长 2 77nm。结果 :HPLC法测定线性范围 0 .96 11～ 48.0 5 5 μg·ml-1,回收率为 99.1% ,RSD为 0 .8%。溶出度测定T50 为 (7.0± 0 .6 )min ,Td 为 (10 .8± 0 .8)min ,m为 (2 .2 2± 0 .0 7)。结论 :HPLC法测定盐酸环丙沙星栓含量 ,方法简捷 ,重现性好 ,可作为制剂质量控制方法。体外溶出度实验显示

OBJECTIVE:To study the determination and the dissolution of ciporfloxain hydrochloride suppository.METHODS:An high performance liquid chromatography was used.RESULTS:In experiment of determination content:The liner response was in the range from 0.961 1 ～ 48.055 μg·ml -1 .The mean recoveries and RSD were 99.1 %, 0.8 %.In experiment of dissolution rate, T 50 was( 7.0 ± 0.6 )min, T d was( 10.8 ± 0.8 )min, m was( 2.22 ± 0.07 ).CONCLUSIONS:The method of determination is simple and sensitive.The dissolution rate of suppository is acceptable.