RP-HPLC法测定双灵固本散中灵芝酸H的含量

Quantitative determination of ganoderic acid H in SunRecome~ by Reversed-phase high performance chromatography

目的建立测定双灵固本散中灵芝酸H含量的RP-HPLC方法。方法采用RP-HPLC法,Zor-bax SB-C18色谱柱（250 mm×4.6 mm,5μm）,以乙腈-体积分数为0.03%的磷酸水溶液为流动相梯度洗脱,流速为1.0 mL·min^-1,检测波长为252 nm,柱温为35℃。结果灵芝酸H的质量浓度在16.34-408.5 mg·L^-1内与峰面积呈良好线性关系,r=0.999 8;平均回收率为99.0%,RSD为2.6%（n=9）。测定的10批双灵固本散样品中,灵芝酸H的含量质量分数均在0.130%-0.348%之间。结论该方法可为双灵固本散的质量控制及质量标准的建立提供了科学的依据。

Objective To develop a RP-HPLC method for the quantitative determination of ganoderic acid H in the SunRecome （traditional Chinese medicines）. Methods The chromatographic separation was achieved on an Agilent Zorbax SB-C18 column （250 mm × 4.6 mm, 5 μm） at 35℃, with a linear gradient of acetonitrile and 0.03% aqueous phosphoric acid （ψ）, at a flow rate of 1.0 mL·min^-1. The detecting wavelength was set at 252 nm. Results The calibration curves showed good linearity （ r 〈 0. 999） within 16.34 - 408.5 kg·L^-1. The average recovery of ganoderic acid H was 99.0 % with RSD of 2.6 % （ n = 9）. This method was successfully applied for analyzing 10 batches of SunRecome . The contents of ganoderic acid H were ranged from 0.130 % to 0. 348 %. Conclusions The method is sensitive, accurate, reliable and suitable for the quality control of the SunRecome .