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目的:建立HPLC法测定亚甲蓝注射液的含量及有关物质。方法:色谱柱:Waters Symmetry C_(18)柱(150 mm×4.6 mm,5μm);流动相:0.3%磷酸溶液-乙晴(70∶30);检测波长:246 nm;柱温:30℃;流速:1.0 ml·min~(-1),进样量:10μl。结果:亚甲蓝峰与杂质峰之间分离度良好;亚甲蓝和杂质A分别在2.0~60.0μg·ml~(-1)(r=0.999 8)和0.2~3.2μg·ml~(-1)(r=0.999 6)浓度范围内与峰面积呈良好的线性关系;亚甲蓝的平均加样回收率为99.75%,RSD为0.86%(n=9)。结论:建立的方法简便、准确,专属性好,精密度高,可用来测定亚甲蓝注射液含量及其有关物质。
Objective: To establish an HPLC method for the determination of methylene blue injection and its related substances. The mobile phase consisted of 0.3% phosphoric acid solution (70:30), detection wavelength (246 nm), column temperature (30 ℃) Flow rate: 1.0 ml · min ~ (-1), injection volume: 10μl. Results: The separation between methylene blue peak and impurity peak was good. Methylene blue and impurity A were detected at 2.0 ~ 60.0μg · ml -1 (r = 0.999 8) and 0.2 ~ 3.2μg · ml -1 ) (r = 0.999 6). The average recoveries of methylene blue were 99.75% with RSD of 0.86% (n = 9). Conclusion: The established method is simple, accurate, specific, and high precision, which can be used to determine the content of methylene blue injection and its related substances.