HPLC法测定山丹酮缓释片中丹参酮类成分的含量

Determination of Tanshinones in Shandantong Retard Tablets by HPLC

目的:建立以高效液相色谱法测定山丹酮缓释片中丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮和二氢丹参酮含量的方法。方法:色谱柱为LichrospherC18(250mm×4·6mm,5μm),流动相为甲醇-水(80:20),检测波长为270nm。结果:丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮和二氢丹参酮的进样量分别在0·20～2·00μg(r=0·9999)、0·30～3·00μg(r=0·9999)、0·20～2·00μg(r=0·9999)和0·20～2·00μg(r=0·9999)范围内与各自峰面积积分值呈良好线性关系;丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮和二氢丹参酮的平均回收率分别为99·54%、98·89%、100·10%、99·44%,RSD分别为0·40%、0·92%、1·30%、1·53%(n=6)。结论:本法简单、快速、准确,可用于山丹酮缓释片的质量控制。

OBJECTIVE： To develop an HPLC method for the determination of Tanshinone Ⅰ , Tanshinone Ⅱ A, Cryptotanshinone, and Dihydrotanshinone in Shandantong retard tablets. METHODS： The samples were separated on Lichrospher C18 column （250 mm×4.6mm,5μm） with the mobile phase consisted of methanol water （80 ： 20）. The detection wavelength was set at 270 nm.RESULTS： The linear ranges of Tanshinone Ⅰ ,Tanshinone Ⅱ A,Cryptotanshinone, and Dihydrotanshinone were 0.20-2.00μg, 0.30-3.00μg, 0.20-2.00μg, and 0.20-2.00μg, respectively. The average recoveries were 99.54%, 98.89%, 100.10%, and 99.44%, respectively with RSD at 0.40%, 0.92%, 1.30% and 1.53% （n = 6）, respectively. CONCLUSION： This method is simple, rapid and accurate, and suitable for the quality control of Shandantong retard tablets.