HPLC法测定泻痢停片中醋酸泼尼松的含量Determination of prednisone acetate in Xie Li Ting tablets by HPLC
钟颖,曾志坚
Zhong Ying;Zeng Zhijian(Jiangmen Institute for Drug Control;
摘要(Abstract)：
目的 建立泻痢停片中醋酸泼尼松的高效液相检测法。方法 色谱柱为HypersilODS2 (5 μm ,4.6mm× 2 0 0mm) ,流动相为甲醇 -水 (5 8∶42 ) ,流速 1.0ml min ,检测波长 2 40nm ,氢化可的松为内标物。结果 醋酸泼尼松和内标的保留时间分别为 11.4min和 7.5min。在 80～ 2 40 μg ml浓度范围内 ,醋酸泼尼松与内标峰面积之比和浓度呈良好的线性关系 (r =0 .9998) ,醋酸泼尼松平均回收率为 99.92 % ,RSD为 0 .2 4%。结论 用高效液相色谱法测定醋酸泼尼松的含量 ,有简便、准确、灵敏度高的优点 ,可用于该制剂的质量控制
Objective To develop a method for analysis of prednisone acetate in Xie Li Ting tablets by HPLC. Methods Separation was obtained by using a hypersil ODS2 (5μm,4.6mm×200mm).The mobile phase consisted of a mixture of methanol water(58 ∶ 42) and the flow rate was 1.0ml/min. The determination warelength was 240nm,using hydrocortisong as internal standard. Results The retention times of prednisone acetate and IS were 11.4 and 7.5min respectively. A linear relationship was obtained between the peak area ratio and the concentration of prednisone acetate from 80 to 240μg·ml -1 . The average recoveries of prednisone acetate was 99.92%,with RSD of 0.24%. Conclusion The method is simple,accurate and sensitve and can be used in determination of prednisone acetate in Xie Li Ting tablets.
关键词(KeyWords)：
泻痢停片;醋酸泼尼松;氢化可的松;高效液相色谱法
Xie Li Ting tablets;prednisone acetate;hydrocortisone;HPLC
基金项目(Foundation):
作者(Authors):
钟颖,曾志坚
Zhong Ying;Zeng Zhijian(Jiangmen Institute for Drug Control;