HPLC法测定骨质宁搽剂中盐酸小檗碱的含量

HPLC Determination of Berberine Hydrochloride in GuZhiNing Liniment

[目的]建立高效液相色谱法测定骨质宁搽剂中盐酸小檗碱(C20H18ClNO4)含量的方法。[方法]C18色谱柱,流动相为乙腈—50mmol.L-1NaH2PO4水溶液(磷酸调PH=2.5)(25∶75),流速1.0mL.min-1,室温,UV348nm检测。[结果]盐酸小檗碱在0.106～0.530μg(n=5)范围内线性关系良好(r=0.9999);方法精密度RSD为0.7%(n=6)。4批样品盐酸小檗碱的含量分别为19.11、18.81、18.83、18.92mg/100mg。[结论]方法专属性强、简便、准确;为该药提供了切实可行的质控方法。

[Objective]To develop an HPLC method for the determination of berberine hydrochloride in GuZheNing liniment. [Methods]The chromatographic system consisted of Dimonsil C18 column and mobile phase of acetonitrile-50mmol · L^-1 sodium dihydrogen phosphate （adjusted PH to 2.5 with H2 PO4） （25 ： 75）. The flow rate was 1.0 mL · min ^-1 , and the detective wavelength was at 348 nm. [Results]The calibration curve was linear in the range of 0. 106-0. 530 btg（rl：5）. The method was proved to be repeatable with RSD 0.7%（n=6）. 4 batches of sample were analyzed and the Berberine Hydrochloride contents were 19. 11, 18.81, 18.83, 18.92mg/100mg, respectively. [Conclusion]The method is selective, simple and accurate, and could be used for the quality control of this preparation.