摘要
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 methylthioninium chloride injection and its related substances. Methods： Octadecylsilane bonded silica was used as the filler. A Waters Symmetry C_（18）column（ 150 mm×4.6 mm,5 μm）was used with the mobile phase of 0.3% phosphoric acid solution-acetonitrile（ 70 ∶ 30）. The detection wavelength was 246 nm and the column temperature was 30 ℃. The flow rate was 1.0 ml·min^（-1）and the injection volume was 10 μl. Results： The separation degree of methylthioninium chloride peak and impurity peaks was good. Methylthioninium chloride within the range of 2.0-60.0 μg·ml^（-1）showed a good linear relationship（ r = 0.9998）. Impurity A within the range of 0.2-3.2 μg·ml^（-1）showed a good linear relationship（ r = 0.999 6）.The average recovery of methylthioninium chloride was 99.75% and RSD was 0.86%（ n = 9）. Conclusion： The method is simple,accurate and specific with high precision. It can be used to determine the content of methylthioninium chloride injection and its related substances.
出处
《中国药师》
CAS
2016年第4期811-813,共3页
China Pharmacist
