HPLC法测定不同厂家注射用还原型谷胱甘肽的含量

Determination of Content of Reduced Glutathione for Injection from Different Manufacturers by HPLC

目的采用HPLC法对3个厂家生产的注射用还原型谷胱甘肽进行含量测定。方法采用Acclaim C18（250mm×4.6 mm,5μm）色谱柱,以（26 mmol·L-1磷酸二氢钾,6 mmol·L-1辛烷磺酸钠,磷酸调p H=3.0）-甲醇（90∶10）为流动相,流速：1.0 ml·min-1,检测波长：210 nm,柱温：30℃。结果还原型谷胱甘肽在37.5～200μg·ml-1浓度范围内线性关系良好（r=0.9998）。平均回收率为100.03%,RSD为1.29%。不同厂家注射用还原型谷胱甘肽的含量不同,均达到药典规定。结论本法简便、专属性良好、准确可靠,可作为注射用还原型谷胱甘肽含量测定的方法。

Objective To determine the content of reduced glutathione for injection from 3 different manufacturers using HPLC. Methods The analytical column was Acclaim ClS （250 mm × 4.6 mm, 5 μm ） and column temperature was 30 ℃. The mobile phase was 26 mmol·L-1 potassium dihydrogen phosphate, 6 mmol ·L-1 octane sulfonic sodium phosphate（pH = 3）-methanol（90： 10）. The flow rate was 1.0 ml .min-1 and the detection wavelength was 210 nm. Results The chromatographic method showed a good linear relationship within the range of 37.5 -200 μg ·ml-1 （ r =0. 9998）. The average recovery was 100.03% （RSD = 1.29% ）. The content of reduced glutathione for injection from different manufacturers varied, all meet requirements in pharmacopoeia. Conclusion This method is simple, specific and accurate, which can be used for determination of the content of reduced glutathione for injection.