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目的建立高效液相色谱法(HPLC)测定胃得安胶囊中盐酸小檗碱含量的测定方法。方法采用Hypersil XB-C18色谱柱;以乙腈—0.1%磷酸(52∶48)为流动相(每100ml加十二烷基磺酸钠0.1g);检测波长为265nm,进样量为10μl,理论塔板数按盐酸小檗碱计算,应不低于4000。结果盐酸小檗碱在0.004684~0.14052μg线性关系良好(r=1);平均回收率为99.57%,RSD=2.03%。结论 HPLC法精密度好,灵敏度高,可作为控制胃得安胶囊质量的方法。
Objective To establish a method for the determination of berberine hydrochloride in Weidean capsule by high performance liquid chromatography (HPLC). Methods The mobile phase consisted of acetonitrile-0.1% phosphoric acid (52:48) (0.1g sodium dodecyl sulfate per 100ml) with a Hypersil XB-C18 column. The detection wavelength was 265nm and the injection volume was 10μl. Number of plates calculated by berberine, should not be less than 4,000. Results Berberine hydrochloride had a good linearity (r = 1) between 0.004684 and 0.14052μg. The average recovery was 99.57% and RSD was 2.03%. Conclusion HPLC method has good precision and high sensitivity and can be used as a method to control the quality of Weidean capsules.