HPLC法测定泌淋清胶囊中盐酸小檗碱的含量___

摘要 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Hypersil ODS2柱（C18，4.6mm×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。

Abstract 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.