HPLC法测定盐酸雷尼替丁的含量及其有关物质的探讨

目的：建立HPLC法测定盐酸雷尼替丁的含量及其有关物质。方法：采用Kromasil C18（150mm×4．6mm，5μm）为色谱柱；检测波长为230nm；流动相采用磷酸盐缓冲液：乙睛（pH7．1）梯度洗脱，流速为1．5ml·min^-1；柱温35℃。结果：盐酸雷尼替丁在0．0521～0．1737mg·ml^-1范围内，峰面积与测定浓度呈良好的线性关系（r=1．0000）；最低检测限1．1ng。结论：该方法对标准的控制更加简便、准确、可行，可用于盐酸雷尼替丁的质量控制。

Discussion of Determination the Content of Ranitidine Hydrochloride and Related Substances by HPLC

Objective ： To establish an HPLC method for determination the content of ranitidine hydrochloride and its related substances. Method ： The Kromasil C18 column （ 150 mm × 4. 6 mm,5 μm） was used, detection wavelength was 230 rim, the mobile phase consisted of a mixture of phosphate buffer and acetonitrile （ pH 7.1 ） with gradient elution at a flow rate of 1.5 ml· min^ - 1, and the column temperature was 35 ℃ . Result： Calibration curve of ranitidine hydrochloride was linear within the range of 0.052 1-0. 173 7 mg · ml ^- 1 （ r = 1. 000 0）. The detection limit was 1.1 ng. Conclusion： The method is simple, accurate, reproducible, and it can be used to control the quality of ranitidine hydrochloride.