HPLC法测定醋酸氟氢可的松有关物质

Determination of fludrocortisone acetate and its related substances by HPLC

目的建立测定醋酸氟氢可的松有关物质的HPLC方法。方法色谱柱YMC Triart C8（4．6mm×150mm，5μm），以乙腈一水流动相，梯度洗脱；检测波长为254nm。结果主成分和相邻杂质能完全分离，醋酸氟氢可的松及4个已知有关物质均在为0．25—10．0mg／L范围内线性关系良好，有关物质的平均回收率为98．0％～102．0％，RSD均小手10％（n=9）。结论本法准确、可靠、灵敏，可用于醋酸氟氢可的松的有关物质测定。

Objective To establish a high performance liquid chromatography （HPLC） method for determination of fludrocortisone acetate and its related substances. Methods HPLC analysis was performed on an YMC Triart C8 column （4.6 mm ×150mm,5μm） , with a mobile phase of acetonltrile - water by gradient elution at a detection wavelength of 254 nm. Results The main component was completed separated from related impurities. Fludrocortisone acetate and its four related substances showed good linearities in a range of 0.20 - 10 mg/L （r = 0. 999）. The recoveries of the related substances were 98.0% - 102.0% , with RSDs 〈 10% （ n = 9 ）. Conclusions The method is sensitive and accurate for determination of fludrocortisone acetate and related substances.