盐酸氨基葡萄糖片高效液相色谱测定方法的改进

Improvement on Determination of Glucosamine Hydrochloride in Glucosamine Hydrochloride Tablets by HPLC

目的改进盐酸氨基葡萄糖片的高效液相色谱测定方法。方法采用Alltima C18色谱柱(250 mm×4.6 mm,5μm),以10 mmol/L磷酸二氢铵溶液-乙腈(95∶5,V/V)为流动相,流速为0.5 mL/min,检测波长为194 nm。结果改进方法后,盐酸氨基葡萄糖的线性关系良好,r=0.999 5;方法专属性强,盐酸氨基葡萄糖和辅料、降解产物、常见酸根离子之间都有良好分离度;方法精密度和稳定性良好,RSD均小于2%;加样回收率良好,百分回收率在99.52%～101.2%之间。结论改进后的方法优于国家食品药品监督管理局注册标准中的方法,可作为盐酸氨基葡萄糖片的含量测定方法。

Objective To improve an HPLC method for the determination of glucosamine hydrochloride in Glucosamine Hydrochloride Tablets.Methods An Alltima C18 column（250 mm×4.6 mm,5 μm） was used for the separation,with 10 mm ammonium dihydrogen phosphate-acetonitrile（95 ∶5） as the mobile phase at the flow rate of 0.5 mL/min.The detection wavelength was 194 nm.Results This method showed good linearity with a correlation coefficient（r） of 0.999 5;the specificity study showed satisfactory resolutions between glucosamine hydrochloride,excipients,forced degradation products and common acid radical negative ions;the precisions and stability were satisfactory with all RSDs below 2%;and the spiked recovery ranged from 99.52%to 101.2%.Conclusion This method is superior to the standard method,and could be used for the determination of glucosamine hydrochloride in Glucosamine Hydrochloride Tablets.