反相HPLC法测定兰索拉唑原料及片剂的含量

Determination of Lansoprazole in the Raw Material and Its Tablets by RP HPLC

介绍反相ＨＰＬＣ法测定兰索拉唑原料及片剂的含量。以Ｃ１８为色谱柱（４．６ｍｍ×２５０ｍｍ），流动相为甲醇－水－三乙胺－磷酸（７００∶３００∶５∶１．５），用磷酸（１→１０）调ｐＨ＝７．３±０．１，检测波长２８４ｎｍ。线性范围在０．５～４．０μｇ，ｒ＝０９９９９；平均回收率为９９．８％，ＲＳＤ＝０．５％（ｎ＝５）。

The contents of lansoprazole in the raw material and its tablets were determined by RP HPLC. Spherisorb C 18 column(4.6mm×250mm) was use. The mobile phase was methanol water triethy lenamine phosphoric acid (700∶300∶5∶1.5),with the pH of 7.3±0.1 adjusted with phosphoric acid. The determination warelength was 284nm. The linear correlation was observed within the range of 0.5～4.0μg(r=0 9999). The average recovery was 99.8%,RSD=0.5%(n=5).