盐酸环丙沙星软膏剂的含量测定及稳定性研究

Determination and stability of the ciprofloxacin hydrochloride ointment

目的 建立盐酸环丙沙星软膏剂的含量测定及储藏方法。方法 用一阶导数分光光度法测定盐酸环丙沙星软膏的含量 ,同时用强化试验、加速试验、长期试验等方法对其稳定性进行研究。结果 一阶导数光谱能消除软膏基质对盐酸环丙沙星软膏剂含量测定的干扰 ,线性范围为 1～ 6mg·L-1 ,回收率在 97%～ 1 0 1 9% (n =5 ) ,日内日间的RSD均小于 1 83% ,加样平均回收率为 99 88% ,RSD =0 36 % (n =5 )。本品对光、热均不稳定。结论 该方法简便 ,准确可靠 ,成本低廉。储藏时应避光 ,密闭 ,置阴凉处 ,储藏保质期

AIM To establish methods for the content determination and the storage of ciprofloxacin hydrochloride ointment. METHODS A first order derivative spectrophotometry method was used. Strengthenin test, accelerating one and long term one were applied to study stability of the ointment, respectively. RESULTS The first order derivative spectrum was able to eliminate the interference of the matrix in ciprofloxacin of the ointment. The linear calibration curve was obtained in the concentration range of 1～6 mg·L -1 . The recovery was between 97%～101 9%( n=5 ), and the within day and between day precisions were good, both of RSDs less than 1 83%. The mean recovery of the ointment was 99 88%, and RSD was 0 36%( n=5 ). The preparation is unstable to light and heat. CONCLUSIONS The method is simple, accurate and cheap. The lifetime of the ointment it one year if it is kept away from light, air and heat.