盐酸丁卡因涂剂的含量测定和稳定性考察

Content Determination and Stability of Tetracaine Hydrochloride Pigment

目的建立盐酸丁卡因涂剂的含量测定方法,并对其稳定性进行考察。方法采用紫外分光光度法,测定波长为310nm;在室温、避光条件下,对不同时间段内的样品进行观察,定期测定含量。结果盐酸丁卡因检测浓度在1.0~20.0μg·ml^(-1)范围内与吸收度呈良好线性关系,r=0.9999,平均回收率为99.58%,RSD为0.75%。盐酸丁卡因涂剂在室温、避光条件下贮存,含量下降较明显。结论建立的紫外分光光度法测定盐酸丁卡因涂剂含量简便、快速、准确,可用于该制剂的含量测定;盐酸丁卡因涂剂的有效期可暂定为12个月。

Objective To establish a method for content determination of tetracaine hydrochloride pigment and study its stability and shelf life.Methods The content of tetracaine hydrochloride pigment was determined with UV spectrophotometry at 310 nm.At different time points,the contents of samples were determined after being stored at room temperature and away from the light.Results The linear range was1.0-20.0μg·ml^-1,r =0.9999.The average recovery was 99.58% and RSD was 0.75%.The content of tetracaine hydrochloride pigment decreased obviously at room temperature and away from the light.Conclusion The established method of UV spectrophotometry is simple,quick and accurate,which is suitable for determination of tetracaine hydrochloride pigment.The shelf life of the pigment can be 12 months at room temperature and away from light.