高效液相色谱法测定透明质酸钠含量的研究

Determination of sodium hyaluronate by HPLC

目的建立一种高效液相色谱法用于定量检测透明质酸钠原料含量,有效实现产品质量控制。方法采用MCI GEL CK08EH色谱柱(8 mm×300 mm,5μm);以1%磷酸为流动相;柱温40℃;流速0.6 mL·min^-1;检测波长232 nm。结果透明质酸钠在0.0~184.1μg·mL^-1范围内其浓度和峰面积有良好的线性关系(r 2=1.0000),平均回收率为103.1%,方法重复性RSD为0.4%(n=6),检出限和定量限分别为0.04μg·mL^-1和0.12μg·mL^-1。结论该方法专属性强,准确度高,重复性好,灵敏度满足要求,适合于透明质酸钠原料的含量控制。

Objective To establish an HPLC method for the determination of sodium hyaluronate.Methods A MCI GEL CK08EH column(4.6 mm×250 mm,50x0E?SymbolmA@0x0Fm)was used with 1%H 3 PO 4 as mobile phase at 40℃,the flow rate was 0.6 mL·min^-1,the detection wavelength was 232 nm.Results The linear range was 0.0~184.1μg·mL^-1(r 2=1.0000)for sodium hyaluronate,the average recovery was 103.1%,with RSD of 0.4%(n=6).The LOD and LOQ was 0.04μg·mL^-1 and 0.12μg·mL^-1.Conclusion The method was sensitive,rapid,accurate and reproducible,and can be used for the quality control of sodium hyaluronate.