HPLC法测定妇复春胶囊中活性成分的研究

Study on the Analytical Methods of Determination of the Contents in Fufuchun Capsule by HPLC

目的:建立妇复春胶囊中维生素A和维生素E含量测定及醋酸甲羟孕酮含量均匀度检查的HPLC分析方法。方法:维生素A和维生素E的含量测定色谱条件为:以十八烷基硅烷键合硅胶为填充剂,甲醇-水(98:2)为流动相,检测波长284nm。醋酸甲羟孕酮含量均匀度的色谱条件为:以十八烷基硅烷键合硅胶为填充剂,以甲醇-水(70:30)为流动相,检测波长240nm。结果:维生素A和维生素E的平均回收率分别为99.6％和100.2％,RSD分别为0.73％和1.0％(n=9);醋酸甲羟孕酮的平均回收率为99.3％,RSD为0.97％(n=9),三批样品的醋酸甲羟孕酮含量均匀度符合规定。结论:选择不同比例的甲醇-水为流动相,在不同检测波长下,采用HPLC方法准确测定了维生素A和维生素E含量及醋酸甲羟孕酮含量均匀度,有效地控制了产品的质量。本方法专属性强,灵敏度高,操作简便快速。

Objective: Two methods about high performance liquid chromatography (HPLC)at the different chromatographic conditions for determination of the contents in Fufuchun capsule were developed. Method: Vitamin A and Vitamin E were analyzed simultaneously on C18 column using methanol-water (98 : 2) as mobile phase and detected at UV 284nm wavelength. The content uniformity of Medroxyprogesterone Acetate in Fufuchun capsule was determined on C18 column with methanol-water (70 : 30) as mobile phase at UV 240nm wavelength. Results:The average recoveries for Vitamin A and Vitamin E were 99. 6% and 100. 2%,RSD were 0. 73% and 1. 0%(n = 9) respectively. The average recovery for Medroxyprogesterone Acetate was 99. 3%,RSD=0. 97%(n = 9). Conclusion:These methods were good in sensibility and specificity. There were not the interfering substance in determining the major components of Fufuchun capsule.