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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 C_(18)(150 mm×4.6 mm,5μm)为色谱柱;检测波长为230 nm;流动相采用磷酸盐缓冲液:乙睛(pH 7.1)梯度洗脱,流速为1.5 ml·min~(-1);柱温35℃。结果:盐酸雷尼替丁在0.052 1～0.173 7 mg·ml~(-1)范围内,峰面积与测定浓度呈良好的线性关系(r=1.000 0);最低检测限1.1 ng。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。
Objective: To establish a HPLC method for the determination of ranitidine hydrochloride and its related substances. METHODS: Kromasil C 18 column (150 mm × 4.6 mm, 5 μm) was used as the detector. The detection wavelength was 230 nm. The mobile phase was eluted with phosphate buffer (pH 7.1) at a flow rate of 1.5 ml. min ~ (-1); column temperature 35 ℃. RESULTS: Ranitidine hydrochloride showed a good linear relationship (r = 1.000 0) with the concentration of ranitidine in the range of 0.052 1 ~ 0.173 7 mg · ml ~ (-1). The minimum detection limit was 1.1 ng. Conclusion: This method is more convenient, accurate and feasible for standard control and can be used for the quality control of ranitidine hydrochloride.