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目的建立反相高效液相色谱法(RP-HPLC)测定复方奥硝唑大黄口腔膜中大黄酸、大黄素及大黄酚的含量。方法使用Fortis Xi C18色谱柱(250 mm×4.6 mm,5μm),甲醇-质量分数为0.1%的磷酸溶液(体积比为85∶15)为流动相,流速为1.0 mL.min-1,检测波长为254 nm。结果大黄酸、大黄素、大黄酚峰与相邻色谱峰分离度均高于3.0,方法专属性强;各组分在测定范围内线性关系良好,回归方程分别为:大黄酚A大黄酚=3.298 3×107ρ-602 4(R2=0.999 0),大黄酸A大黄酸=2.138 3×107ρ-576 2(R2=0.997 0),大黄素A大黄素=2.075 0×107ρ-489 1(R2=0.9990);各组分加样回收率均高于94.0%。测得复方奥硝唑大黄口腔膜中大黄酸、大黄素、大黄酚的平均含量为353、106、121μg.cm-2。结论本方法测定奥硝唑大黄口腔膜中大黄酸、大黄素及大黄酚,可应用于奥硝唑大黄口腔缓释膜剂的质量控制。
Objective To establish an RP-HPLC method for the determination of rhein, emodin and chrysophanol in compound ornidazole rhubarb oral films. Methods The mobile phase was a Fortis Xi C18 column (250 mm × 4.6 mm, 5 μm) with a methanol-0.1% phosphoric acid solution (85:15 by volume) at a flow rate of 1.0 mL · min-1. The detection wavelength 254 nm. Results The separation of rhein, emodin and chrysophanol peak from the adjacent chromatographic peaks was higher than 3.0, and the method was more specific. The linearity of each component in the determination range was good. The regression equations were as follows: chrysophanol A chrysophanol = 3.298 3 × 107ρ-602 4 (R2 = 0.999 0), rhein A rhein = 2.138 3 × 107ρ-576 2 (R2 = 0.997 0), emodin A = 2.075 × 107ρ-489 1 (R2 = 0.9990 ); The recoveries of all components were higher than 94.0%. Measured compound ornidazole rhubarb oral membrane rhein, emodin, chrysophanol average content of 353,106,121 g.cm-2. Conclusion The method for the determination of ornidazole rhubarb oral film rhein, emodin and chrysophanol, ornidazole rhubarb oral sustained release film quality control.