RP-HPLC测定泼尼松龙的原料和片剂中有关物质

Determination of the related substances in Prednisolone and its tablet by RP-HPLC

目的建立泼尼松龙原料及其片剂中有关物质的检查方法。方法采用高效液相色谱法，色谱柱为Dikma Diamonsil^TM C18（200mm×4．6mm，5μm）柱；流动相为甲醇-水（60-40）；检测波长246nm。结果有关物质检查的检测限为1.6ng（S／N=3），线性范围0．04-0．8μg（r=0．9998）。结论所建立的方法简便、灵敏、快速，可用于泼尼松龙原料和片剂中有关物质的检查和质量控制。

OBJECTIVE To develop a method for determining the related substances in Prednisolone and its tablet. METHODS RP - HPLC was adopted. The column was Dikma Diamonsil^TM C18 （200mm×4.6mm,5μm）, the mobile phase was methanol -water （60：40） , and the detection wavelength was 246 nm. RESULTS The calibration curve was linear in the range of 0. 041 -0. 480μg （ r = 0. 9998）. The detective limit was 1.6 ng （ S/N = 3 ）. CONCLUSION The method is simple, sensitive and suitable for the examination of related substances in Prednisolone and its tablet.