高效液相色谱法测定D-泛酸钠及有关物质

目的建立测定D-泛酸钠及有关物质的高效液相色谱法。方法采用色谱柱为shim pack ODS C18柱;流动相:乙腈:0.05mol.L-1磷酸二氢钾(用磷酸调pH至3.0)为8∶92;流速:1.0mL.min-1;检测波长:210nm;柱温:35℃。结果在建立的色谱条件下,D-泛酸钠与杂质分离完全;在浓度0.1~1.5mg.mL-1范围内呈良好的线性关系(r=0.9999);重复性试验的RSD为0.69%;最低检测限为0.5μg.mL-1。3批D-泛酸钠样品的有关物质分别为0.65%,0.62%,0.69%。结论该法简便、快捷,可以用于测定D-泛酸钠含量,检查原料中的有关物质。

Determination of D-sodium pantothenate and the related substances by HPLC

OBJECTIVE To establish an HPLC method for the determination of D-sodium pantothenate and its related substances.METHODS A Shimpack ODS-C18 column（4.6mm×150mm,5μm） was adopted;The mobile phase was acetonitrile-0.05mol·L-1 potassium dihydrogen phosphate solution（8∶92,adjusted to pH 3.0 with phosphoric acid）,at a flow rate of 1.0mL·min-1,detection was done at 210nm.RESULTS Under the described chromatographic condition,D-sodium pantothenate was completely separated from its impurities.D-sodium pantothenat had a good linear relation in the range of 0.1～1.5mg·mL-1（R=0.9999）;the RSD of repeatability was 0.69%.The detection limit was 0.5μg·mL-1.The impurity rate of three batches of D-sodium pantothenate samples was 0.65%,0.62%,0.69%.CONCLUSION The method is accurate,simple and convenient,can be used for the determination of D-sodium pantothenat and its related substance.