高效液相色谱法测定维U颠茄铝镁片中硫酸阿托品含量

Determination of Atropine Sulfate in Vitamin U,Aluminium Hydroxide and Mangesium Trisilicate Tablets by HPLC

目的用高效液相色谱法测定维U颠茄铝镁片中硫酸阿托品的含量。方法采用Phenomenex C18色谱柱(250 mm×4.6mm,5μm),以0.5%三乙胺溶液(0.2%四氢呋喃,用冰醋酸调pH至6.10)-乙腈(80∶20)为流动相,检测波长为210 nm,柱温为室温。结果硫酸阿托品质量浓度在24.18～290.16μg/mL范围内与峰面积线性关系良好(r=0.9998),平均回收率为97.21%,RSD=1.1%(n=5)。结论该法简便、快速、准确且专属性强,可用于产品的质量控制。

Objective To establish a HPLC method for the determination of atropine sulfate in Vitamin U,Aluminium Hydroxide and Mangesium Trisilicate Tablets.Methods The HPLC system consisted of the Gemini Phenomenex C18 column（250 mm×4.6mm,5 μm）,with 0.5%triethylamine solution（0.2%tetrahydrofuran,adjusting pH value to 6.10 with glacial acetic acid）-acetonitrile（80 ∶20） as the mobile phase and the detection wavelength of 210 nm.Results The linear range of atropine was 24.18-290.16 μg/mL（r=0.999 8）.The mean recovery rate was 97.21%,RSD=1.1%（n=5）.Conclusion This method is proved to be simple,rapid,accurate and exclusive.