HPLC法测定泌淋清胶囊中盐酸小檗碱的含量

HPLC determination of berberine hydrochloride in Milinqing capsules

目的:建立HPLC法测定泌淋清胶囊中盐酸小檗碱含量的方法。方法:采用HypersilODS2柱(4.6mm×250mm,5μm);以乙腈-0.05mol·L-1三乙胺溶液(29∶71)(用磷酸调节pH至3.0)为流动相,流速为1.0mL·min-1,检测波长为345nm,进样量为10μL;柱温为室温。结果:盐酸小檗碱进样量在0.11～0.63μg范围内呈良好的线性关系,r=0.9998。精密度试验RSD为0.54%,重复性试验RSD为0.95%,平均回收率为99.85%,RSD=0.73%(n=5)。结论:该方法简便、可靠、准确,可用于该制剂的质量控制。

Objective： To establish a method of HPLC determination for Dangejingshu Capsule. Methods： Employed Hypersil ODS2 column （4.6mmx250mm,5μm）, Acetonitrile-0.05mol？L-1 triethylamine [and pH was adjusted to 3.0 with phosphoric acid] （29：71） as mobile phase （a flow rate of l.0 mL？min-1 ）, 345 nm as ultraviolet detection wavelength, column temperature at room temperature and injection volume 10 μL. Results： The calibration curve of berberine hydrochloride showed a good linearity within the range of 0.11～0.63μg, r=0.9998. The average recovery was 99.85% and RSD was 0.73%（n=5）.Conclusion： The method is simple, rapid and specific with accurate and reliable results, which can be used to control the quality of products effectively.