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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 :盐酸环丙沙星栓溶出速率较好
OBJECTIVE: To establish a HPLC method for the determination of ciprofloxacin hydrochloride suppository and investigate its in vitro dissolution. Methods: The Ultrasphere ODS column was used. The mobile phase consisted of methanol, acetonitrile and 0.1mol·L-1 potassium dihydrogen phosphate (5: 4: 9). The detection wavelength was 2 77nm. Results: The linear range of HPLC was 0.96 11 ~ 48.0 55 μg · ml-1, the recovery was 99.1% and the RSD was 0.8%. T50 was (7.0 ± 0.6) min, Td was (10.8 ± 0.8) min, and m was (2.22 ± 0.07). Conclusion: HPLC method for determination of ciprofloxacin hydrochloride suppositories, simple and reproducible, and can be used as a method of quality control. In vitro dissolution test showed: ciprofloxacin hydrochloride plug dissolution rate is better