摘要:
目的 建立HPLC法测定3种不同剂型六味地黄丸中没食子酸、马钱苷、芍药苷和丹皮酚含量的方法。 方法 色谱柱为Agilent ZorbaxSB-C18柱(250 mm×4.6 mm,5 μm);流动相为二元梯度系统,其中溶剂A为乙腈,溶剂B为0.1%甲酸水溶液,梯度洗脱:(0~3 min,A为3%;3 min,A为5%;28 min,A为22%;40 min,A为60%),流速:1 ml/min; 柱温:25℃;检测波长:240 nm;自动进样10 μl。 结果 没食子酸、马钱苷、芍药苷和丹皮酚浓度分别在6.296~318.9 μg/ml(r=0.999 8)、1.952~99.04 μg/ml(r=0.999 7)、6.186~309.3 μg/ml(r=0.999 8)和7.147~214.4 μg/ml(r=0.999 7)范围内呈现良好的线性,精密度实验RSD均小于2%,加样回收率98.2%~102.3%。 结论 该测定方法简便、准确,分离效果好,能同时测定4种成分的含量,适用于不同剂型六味地黄丸的质量控制。
Abstract:
Objective To develop a new high performance liquid chromatography (HPLC) method for simultaneous determination of four major components (gallic acid, loganin, paeoniflorin and paeonol) in different dosage forms of Liuweidihuang. Methods The chromatography condition was with Agilent Zorbax SB-C18 column (4.6×250 mm, 5 μm);mobile phase was A:ACN, B:0.1% formic acid, gradient elution, 0~3 min, A:3%~5%;3~18 min, A:5%~22%;18~60 min, A:22%~60%, flow speed was 1.0 ml/min, temperature of column was 25℃, inject volume was 10 μl, detection wavelength was 240 nm. Results The linearity was obtained over 6.296~318.9 μg/ml(r=0.999 8)for gallic acid, 1.952~99.04 μg/ml(r=0.999 7)for loganin, 6.186~309.3 μg/ml(r=0.999 8)for paeoniflorin and 7.147~214.4 μg/ml(r=0.999 7)for paeonol.The RSDs of precision of the samples were both less than 2%.The average recovery was between 98.2%~102.3%. Conclusion The present method, with satisfactory efficacy, was accurate and simple which could simultaneously determine four components, and could be used for quality control of different dosage forum of Liuweidihuang.
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