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目的:用高效液相色谱法测定注射用法莫替丁中有关物质的含量。方法:采用Diamonsil C 18色谱柱;以0.01mol.L-1庚烷磺酸钠溶液-乙腈-甲醇(25∶6∶1),用冰醋酸调节pH至3.9;流速:1.0ml/min,检测波长为267nm。结果:有关物质的浓度在106～317μg.ml-1范围内均与峰面积呈良好的线性关系,r为0.9712,法莫替丁与有关物质能有效分离,有关物质的最低检测限(S/N=3)为0.02 ng.ml-1。结论:此方法简便、快速、准确,可用于该药有关物质的检查。
Objective: To determine the content of related substances in famotidine for injection by high performance liquid chromatography. Methods: Diamonsil C 18 column was used. With 0.01mol.L-1 heptane sulfonate solution-acetonitrile-methanol (25: 6:1), the pH was adjusted to 3.9 with glacial acetic acid. The flow rate was 1.0ml / The wavelength is 267nm. Results: The concentration of the related substances showed a good linear relationship with the peak area in the range of 106 ~ 317μg.ml-1, r was 0.9712, the separation of famotidine and related substances was effective, and the detection limit of S / N = 3) was 0.02 ng.ml-1. Conclusion: This method is simple, rapid and accurate, which can be used to check the related substances of this medicine.