HPLC测定疏经防痛胶囊中芍药苷和丹参酮Ⅱ_A含量

Determination of Paeoniflorin and Tanshinone Ⅱ_A in Shujing Fangtong Capsules by HPLC

目的：建立HPLC测定疏经防痛胶囊中芍药苷、丹参酮ⅡA含量的方法,为该制剂的临床推广提供参考。方法：芍药苷和丹参酮ⅡA的色谱柱分别选择Luna 5u C18（4.6 mm×250 mm,5μm）和Diamonsil C18（4.6 mm×250 mm,5μm）,流动相分别为0.05%磷酸二氢钾-乙腈（85∶15）和甲醇-水（80∶20）,检测波长分别为230 nm和270 nm,进样量分别为10μL和20μL,柱温均为25℃。结果：芍药苷、丹参酮ⅡA的线性范围分别为0.020 4-0.204,0.043 2-0.864μg;平均加样回收率分别为99.89%（RSD 1.5%）,100.43%（RSD 1.1%）,重复性、稳定性、精密度试验的RSD均〈2%。结论：建立的方法简便、定量准确、重复性好,适用于疏经防痛胶囊的质量控制。

Objective： To establish an HPLC method for determination of paeoniflorin and tanshinone Ⅱn in Shujing Fangtong capsules. Method： Chromatographic test on paeoniflorin was performed on Luna 5u Cls column （4.6 mm × 250 mm, 5 μm） , mobile phase consisted of acetonitrile-0.05% monopotassium phosphate （15：85）, detection wavelength was 230 nm, column temperature was 25 ℃, injection volume was 10 μL, flow rate was 1.0 mL ·min^-1 Similarly, chromatographic test on tanshinone HA was performed on Diamonsil CIS column （4.6 mm ×250 mm, 5 μm） , mobile phase was methanol-water （80：20） , detection wavelength was 270 nm, column temperature was 25 ℃ , injection volume was 20 μL and flow rate was 1.0 mL ·min^-1. Result： Linear ranges of paeoniflorin and tanshinone Ⅱ A were 0. 020 4-0. 204, 0. 043 2-0. 864 p,g, average recoveries of them were 99.89% （RSD 1.5% ） and 100.43% （RSD 1.1% ）, respectively. RSDs of repeatability, stability and precidion test were less than 2%. Conclusion： This method is simple, accurate with good repeatability, which is suitable for quality control of Shujing Fangtong capsples.