HPLC法同时测定双石通淋胶囊中8个成分的含量  

Simultaneous determination of eight components in Shuangshi Tonglin capsules by HPLC

作　　者：唐蕾 刘伟 陆静娴 TANG Lei;LIU Wei;LU Jing-xian(Shanghai Xuhui Institute for Food and Drug Control,Shanghai 200237,China;Zhejiang Institute for Food and Drug Control,Hangzhou,310053,China)

机构地区：[1]上海市徐汇食品药品检验所,上海200237 [2]浙江省食品药品检验研究院,杭州310053

出　　处：《药物分析杂志》2024年第8期1303-1309,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法同时测定双石通淋胶囊中丹参素钠、京尼平苷酸、黄柏碱、丹酚酸B、巴马汀、小檗碱、苍术素、丹参酮Ⅱ_(A)8个成分的含量。方法:采用Capcell Pak MGⅡC18(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-0.1%磷酸水-水(含0.1%磷酸和0.2%三乙胺,pH=6.0),梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,进样量为10μL,检测波长分别为280 nm(0~13.4 min,丹参素钠)、238 nm(13.5~17.0 min,京尼平苷酸)、280 nm(17.1~51.0 min,黄柏碱和丹酚酸B)、345 nm(51.1.1~70.0 min,巴马汀和盐酸小檗碱)、336 nm(70.1~78.0 min,苍术素)和268 nm(78.1~90.0 min,丹参酮Ⅱ_(A))。结果:丹参素钠、京尼平苷酸、黄柏碱、丹酚酸B、巴马汀、小檗碱、苍术素、丹参酮Ⅱ_(A)8个成分在各自线性范围内线性关系良好,相关系数均≥0.9995;精密度、稳定性、重复性试验的RSD均小于2.0%;平均回收率分别为101.3%、98.2%、97.3%、98.1%、96.6%、97.9%、98.7%、99.6%,RSD均小于2.0%。3批样品中上述8个成分的含量范围分别为4.47~5.51、0.93~1.44、1.00~1.07、5.72~8.67、0.64~0.69、1.62~1.90、0.055~0.088、0.29~0.44 mg·g^(-1)。结论:该方法快速、灵敏,专属性高,可用于同时测定双石通淋胶囊中8个成分的含量。Objective:To establish an HPLC method for the simultaneous determination of eight components including salvianic acid A sodium,geniposidic acid,phellodendrine,salvianolic acid B,palmatine,berberine,atractylodin,tanshinoneⅡ_(A)in Shuangshi Tonglin capsules.Methods:The determination was performed on a Capcell Pak MGⅡC_(18)column(250 mm×4.6 mm,5μm)with the mobile phase consisting of acetonitrile-water(containing 0.1%phosphoric acid)-water(containing 0.1%phosphoric acid and 0.2%triethylamine,pH 6.0)in a gradient mode at a flow rate of 1.0 mL·min^(-1).The column temperature was set at 30℃,the injection volume was 10μL,and the detection wavelength was 280 nm(0-13.4 min)for salvianic acid A sodium,238 nm(13.5-17.0 min)for geniposidic acid,280 nm(17.1-51.0 min)for phellodendrine,salvianolic acid B,345 nm(51.1.1-70.0 min)for palmatine,berberine,336 nm(70.1-78.0 min)for atractylodin and 268 nm(78.1-90.0 min)for tanshinoneⅡ_(A).Results:Salvianic acid A sodium,geniposidic acid,phellodendrine,salvianolic acid B,palmatine,berberine,atractylodin,tanshinoneⅡ_(A)had good linearities in their respective linear ranges with all linear correlation coefficients≥0.9995 and RSDs of the precision,repeatability and stability less than 2.0%.The average recoveries were 101.3%,98.2%,97.3%,98.1%,96.6%,97.9%,98.7%,99.6%,with RSDs lower than 2.0%.The contents of the above eight components in three batches of samples was 4.47-5.51 mg·g^(-1),0.93-1.44 mg·g^(-1),1.00-1.07 mg·g^(-1),5.72-8.67 mg·g^(-1),0.64-0.69 mg·g^(-1),1.62-1.90 mg·g^(-1),0.055-0.088 mg·g^(-1),0.29-0.44 mg·g^(-1),respectively.Conclusion:The proposed method is rapid,sensitive and specific,which can be used for determination the contents of eitht components in Shuangshi Tonglin capsules.

关 键 词：双石通淋胶囊 高效液相色谱法 丹参素钠 京尼平苷酸 盐酸黄柏碱 丹酚酸B 巴马汀 小檗碱 苍术素 丹参酮Ⅱ_(A) 

分 类 号：R917[医药卫生—药物分析学]