高效液相色谱法测定肛泰栓中盐酸小檗碱的含量

Determination of Berberine hydrochloride in Gangtai suppositories by HPLC

目的建立高效液相色谱法测定肛泰栓中盐酸小檗碱含量的方法。方法色谱柱:Phenomenexluna C18(2)柱,(5μm,250mm×4.60mm);0.05mol/L磷酸二氢钠溶液(磷酸调节至pH为3)-乙腈(70︰30)为流动相;检测波长:270nm。结果盐酸小檗碱在0.06～0.30μg(r=0.9999,n=5)范围内线性关系良好,平均回收率为98.9%,RSD为2.00%。结论本法简便、快速、专属性强,能满足该制剂的质量控制要求。

Objective To develop an HPLC method for the determination of berberine hydrochloride in Gangtai suppositories. Methods The HPLC system consisted of Phenomenex luna C18 （2） （5 um, 250 mm×4.60 mm）; Using the 0.05 mol/L sodium dihydrogen phosphate （pH=3）： acetonitrile as the mobile phase, the rate of mobile phase was 70：30;The detective wavelength was 270 nm. Results The calibration curve was linear in the range of 0.06-0.3 ug （r=0.999, n=5）; The average recovery was 98.9%, RSD=2.00%. Conclusion This method is reliable,accurate, and convenient. It can satisfy the quality control of the preparation.