HPLC法测定氨糖美辛肠溶片的溶出度

Determination of the dissolution of Glucosamine and Indomethacin Enteric-coated Tablets by HPLC

目的建立氨糖美辛肠溶片溶出度的方法。方法用安捷伦C18色谱柱(4.6mm×250mm,5μm),0.1mol·L^-1的冰醋酸溶液-乙腈(50∶50)为流动相,检测波长为320nm。用高效液相色谱(HPLC)法和紫外法比较测定结果。结果吲哚美辛在1.03~10.3μg·mL^-1的范围内线性关系良好(r=0.9999)。回收率为99.9%。结论该方法快速、准确、重复性好,为氨糖美辛肠溶片的质量控制提供依据。

Objective To establish a method of dissolution test in Glucosamine and Indomethacin Enteric-coated Tablets by HPLC method.Methods Agilent C 18(4.6 mm×250 mm,5μm)Column was used with the mobile phase of 0.1 mol·L^-1 acetic acid-acetonitrile(50∶50).The determination wavelength was 320 nm.The method of HPLC and the method of UV was compared.Results Indomethacin was linear within the concentration range of 1.03~10.3μg·mL^-1(r=0.999 9,n=6).The average recovery was 99.9%.Conclusion The result showed that the method was simple,accurate,good reproducibility and can be used for the quality control.