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目的应用高效液相色谱-二极管阵列检测器(HPLC-DAD),建立复方尿维氨滴眼液中硫酸软骨素钠,尿囊素和维生素B6含量的同时测定方法。方法采用AlltimaC18色谱柱(4.6mm×250mm,5μm),以25mmol·L-1磷酸二氢铵(含0.01%辛烷磺酸钠)-乙睛(95∶5)为流动相,流速0.5mL˙min-1,室温测定,硫酸软骨素钠,尿囊素和维生素B6的检测波长分别为195,215和291nm。结果硫酸软骨素钠,尿囊素和维生素B6的线性关系良好,线性相关系数(r)都大于0.9996;专属性强,3种成分和药品中其他成分以及强制降解产物之间都有良好的分离度;精密度和稳定性良好,峰面积的相对标准偏差(RSD)都小于2.0%;加样回收率良好,在99.01%~101.92%之间。结论该方法准确、简单、快速,可作为复方尿维氨滴眼液中硫酸软骨素钠,尿囊素和维生素B6的同时测定。
Objective To establish a simultaneous determination method for the content of sodium chondroitin sulfate, allantoin and vitamin B6 in compound uricarbazide eye drops by HPLC-DAD (High Performance Liquid Chromatography-Diode Array Detector). Methods Alltima C18 column (4.6 mm × 250 mm, 5 μm) was used with a mobile phase of 25 mmol·L -1 ammonium dihydrogen phosphate (containing 0.01% sodium octane sulfonate) and acetonitrile (95: 5) min-1, measured at room temperature, sodium chondroitin sulfate, allantoin and vitamin B6 detection wavelength were 195,215 and 291nm. Results The linear relationship between sodium chondroitin sulfate, allantoin and vitamin B6 was good, and the linear correlation coefficients (r) were all greater than 0.9996. There was a strong specificity between the three components and other components in the drug products and forced degradation products The precision and stability were good. The relative standard deviations (RSDs) of peak area were all less than 2.0%. The recoveries of samples were good, ranging from 99.01% to 101.92%. Conclusions This method is accurate, simple and rapid and can be used as a simultaneous determination of sodium chondroitin sulfate, allantoin and vitamin B6 in compound urinary retinol eye drops.