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目的:建立眠尔乐胶囊中褪黑素的含量测定方法。方法:采用HPLC和UV法分别测定眠尔乐胶囊中褪黑素的含量,考察二者的准确性、精密性、专属性及回收率,比较二者含量测定结果。结果:HPLC法中褪黑素的线性范围为0.24～2.42μg(r=0.999 9),平均回收率为100.09%,RSD为1.78%(n=6);UV法中褪黑素的线性范围为11.96～23.92mg.L-1(r=0.999 8),平均回收率为100.23%,RSD为0.74%(n=6)。结论:2种方法测定结果经统计学处理差异无显著性(P>0.05),但UV法更简便易操作且设备要求低,故选择UV法作为眠尔乐胶囊的质量控制方法。
Objective: To establish a method for determination of melatonin in Citral Capsule. Methods: The contents of melatonin in Mingle capsules were determined by HPLC and UV respectively. The accuracy, specificity, specificity and recovery of the two compounds were investigated. Results: The linear range of melatonin in HPLC was 0.24-2.42μg (r = 0.999 9), the average recovery was 100.09% and the RSD was 1.78% (n = 6). The linear range of melatonin in UV was 11.96 ~ 23.92mg.L-1 (r = 0.999 8). The average recovery was 100.23% with RSD of 0.74% (n = 6). Conclusion: There is no significant difference between the two methods (P> 0.05). However, the UV method is more simple and easy to operate and requires less equipment. Therefore, the UV method was chosen as the quality control method for Capsule.