反相高效液相色谱法测定神经酸片剂中神经酸含量

Determination of Nervonic Acid in Nervonic Acid Tablets by Reversed Phase High Performance Liquid Chromatography

目的建立神经酸片剂中神经酸的反相高效液相色谱含量测定方法。方法色谱柱为UltimateR XB-C8 (4. 6 mm×250 mm,5μm),流动相为0.1%(V/V)磷酸水溶液-乙腈(93:7),检测波长为203 nm,流速1.0 m L/min,柱温25℃。结果神经酸与其他组分分离良好,神经酸浓度在0.01~0.2 mg/m L范围内线性关系良好(Y=3 000 000 X (mg/m L)+4 795.9,P=0.000,R2=0.999 9,n=5),该方法精密度实验RSD为1.80%(n=6)。样品溶液在24 h稳定,峰面积RSD为1.52%(n=6)。回收率为96.94%~104.46%(RSD在0.81%~3.80%之间)。结论首次采用C8柱,建立了一种反相高效液相色谱方法,实现了对片剂中神经酸含量的快速准确测定。

Objective To establish a RP-HPLC method for the determination of nervonic acid in nervonic acid tablets.Methods Ultimate XB-C8(4.6 mm×250 mm,5μm)column was used.The mobile phase consisted of 0.1%(V/V)phosphoric acid aqueous solution-acetonitrile(93:7).The detection wavelength was 203 nm.The flow rate was 1.0 mL/min.And the column temperature was 25℃.Results Nervonic acid peak was well separated from other components.Nervonic acid showed a good linear relationship in the concentration range of 0.01-0.2 mg/mL with the peak area(Y=3000000 X(mg/mL)+4795.9,R2=0.9999,n=5).The precision RSD%of this method was 1.80%,which met the requirements.The sample had good stability within 24 hours with a RSD%of 1.52%bystability test.The recovery rate was between 96.94%and 104.46%(RSD was between 0.81%and 3.80%).Conslusion For the first time,the C8 column was used in reversed phase high performance liquid chromatography to directly and accurately determine the content of nervonic acid in tablets.