高效液相色谱法测定盐酸雷尼替丁的含量

The Determination of Ranitidine Hydrochloride in the Presence of its Degradants by RP-HPLC

目的：建立一种适用于盐酸雷尼替丁原料药的含量测定方法。方法：采用反相高效液相色谱法，Shimadzu ODS柱（250mm×4．6mm，10μm），甲醇-0．001mol／L磷酸氢二钠溶液（40：60）为流动相，检测波长为320nm，柱温40℃，流速1．0mL．min．采用导数色谱法鉴定了色谱峰纯度，并与中国药典收载的色谱条件进行了比较。结果：盐酸雷尼替丁在20～500μg·ml^-1范围内，峰面积与浓度的线性关系良好（r^2=0．9996）；平均回收率为100．15％，重现性试验RSD=0．41％（n=6）。与中国药典收载的色谱条件相比较，盐酸雷尼替丁与相邻杂质分离更完全。结论：所建立的方法简便、准确、重复性好，可作为盐酸雷尼替丁稳定性及降解动力学研究的含量测定方法。

Objective. Establishing an HPLC method that is applicable to the analysis of Ranitidine Hydrochloride in the presence of its degradants; Methods： Resolving drug peak with Peak homogeneity was assessed by the shape of the derivative spectroscopy. And Shimadzu ODS column （250 mm × 4. 6 mm, 10 μm） was used. The mobile phase was methanol-0. 001 mol/L disodium hydrogen phosphate （40. 60） and the flow rate was 1.0 ml · min^-1. The UV detective wavelength was 320 nm; Results. The calibration curve was linear in the range of 20 ～ 500μg · ml^-1 （r^2 = 0. 9996）. The average recovery was 100.15% with RSD of 0.48%. And the method precision was 0.41% （n=6） ; Conclusion： The method is selective, simple and accurate. And it is applicable to analyze the ranitidine hydrochloride in the presence of its degradants.