HPLC测定硝呋噁酮片剂中硝呋噁酮及有关物质的含量

Determination of Nifuratel and Its Related Compounds in Tablets by RP-HPLC

目的 建立 RP- HPL C法测定硝呋酮片中硝呋酮及其有关物质的含量。方法 以甲醇 -水 ( 45∶ 5 5 ,v/ v)为流动相 ,L ichrospher C1 8色谱柱 ( 5μm,6.0 mm× 15 0 mm )为固定相 ,流速为 1ml/ min,检测波长 2 10 nm。结果 辅料对样品测定不干扰 ,硝呋酮在 1～ 3 0 0 μg/ m l浓度范围内线性关系良好 ,RSD为 0 .76% ,平均回收率为99.6% ,最低检测限为 15 .1ng/ ml。

AIM The purpose is to develop RP-HPLC method for the assay of nifuratel and its related compounds in nifuratel tablets. METHODS Separation was performed on a Lichrospher C 18 column. The mobile phase consists of CH 3OH∶H 2O(45∶55,v/v). The flow rate was 1 ml/min. The UV detection was set at 210 nm. RESULTS The excipient did not interfere with nifuratel. Nifuratel had a good linear relation in the range of 1～300 μg/ml, the RSD was 0.76%, the average recovery was 99.6% and the limit of detection was 15.1 ng/ml. CONCLUSION The method was simple, sensitive and rapid.It can be applied to the determination of nifuratel and related compounds in nifuratl tablets.