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目的:采用反相高效液相色谱法测定甲磺酸酚妥拉明泡腾片的含量及其有关物质。方法:采用C18柱,以醋酸溶液(取冰醋酸1 ml,加水至1 000 ml,用三乙胺调节p H值至3.8)-甲醇(53∶47)为流动相;流速为1.0 ml·min-1;检测波长为278nm。结果:杂质峰与主峰均能有效分离,甲磺酸酚妥拉明在12.008~48.032μg·ml-1浓度范围内线性关系良好(r=0.999 9),平均回收率为99.52%,RSD为0.73%(n=9)。结论:本法简便、准确,专属性好,为提高甲磺酸酚妥拉明泡腾片现行标准提供了参考依据。
Objective: To determine the content of phentolamine effervescent effervescent tablets and its related substances by reversed-phase high performance liquid chromatography. Methods: C18 column was used. The mobile phase consisted of acetic acid solution (1 ml of glacial acetic acid, water up to 1 000 ml and p H value of 3.8 with triethylamine) -methanol (53:47) as mobile phase. The flow rate was 1.0 ml · min -1; detection wavelength of 278nm. Results: The peak of impurities and main peak were separated effectively. The linearity of phentolamine mesylate was 12.008 ~ 48.032μg · ml-1 (r = 0.999 9), the average recovery was 99.52% and the RSD was 0.73 % (n = 9). Conclusion: This method is simple, accurate and specific, and provides a reference for improving the current standard of phentolamine mesylate effervescent tablets.