D-氨基葡萄糖硫酸钾盐含量测定方法探讨

Discussion on Assay Method of D-Glucosamine Sulfate Potassium Chloride

目的对D-氨基葡萄糖硫酸钾盐的含量测定方法的适用性进行验证。方法采用Zorbax C8(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-0.05%磷酸(pH=3.0)(40∶60),流速0.6 mL.min-1,检测波长195 nm。结果D-氨基葡萄糖盐酸盐对照品和D-氨基葡萄糖硫酸钾盐样品图谱中的主峰可能不是D-氨基葡萄糖峰,而是Cl-峰;在药典规定的色谱条件下,D-氨基葡萄糖硫酸钾盐中的SO42-峰与主峰Cl-峰重叠,干扰主峰的测定。结论需进一步改进和完善D-氨基葡萄糖硫酸钾盐的含量测定方法。

OBJECTIVE To validate the validity of assay method of D-Glucosamine Sulfate Potassium Chloride. METHODS The determination was performed on a Zorbax C8 column（4.6 mm × 250 mm,5 μm） with acetonitrile-0.05% Phosphate buffer（ pH = 3.0） （40： 60） as the mobile phase, the flow was 0.6 mL · min^-1 ,wavelength of detection was 195 nm. RESULTS Main peaks in chromatogram of D-Glucosamine Hydrochloride RS and D-Glucosamine Sulfate Potassium Chloride may be not glucosamine peak but Cl^- peak. On the chromatography conditions in USP, SO4^2- peak of D-Glucosamine Sulfate Potassium Chloride overlays with main peak of Cl^ - , and interfere the determination of main peak. CONCLUSION It is necessary to revalidate the method of analytical D- Glucosamine Sulfate Potassium Chloride.