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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 HPLC method for the determination of berberine hydrochloride in the Milinqing Capsule. Methods: A Hypersil ODS2 column (4.6 mm×250 mm, 5 μm) was used; acetonitrile-0.05 mol·L-1 triethylamine solution (29:71) (pH adjusted to 3.0 with phosphoric acid) was used as the mobile phase, and the flow rate was 1.0 mL·min. -1, detection wavelength is 345 nm, injection volume is 10 μL; column temperature is room temperature. Results: The calibration curve of berberine hydrochloride in the range of 0.11～0.63μg showed a good linear relationship, r=0.9998. The precision test RSD was 0.54%, the repeatability test RSD was 0.95%, the average recovery was 99.85%, and the RSD was 0.73% (n=5). Conclusion: The method is simple, reliable and accurate and can be used for the quality control of the preparation.