高效液相色谱法测定复方马来酸依那普利片中两组分的含量

Determination of Two Constituents in Enalapril Maleate Composite Tablets by HPLC

本文建立了复方马来酸依那普利片的高效液相色谱法。在苯基柱上，以阿替洛尔为内标，同时测定复方马来酸依那普利片中氢氯噻嗪、马来酸依那普利的含量。固定相为Ｃ６Ｈ５柱（５μｍ），流动相为甲醇—０．０３ｍｏｌ／Ｌ磷酸二氢钾液（３０∶７０，ｐＨ４．０）。氢氯噻嗪的回收率为９９．６％（ｎ＝７），ＲＳＤ＝０．５％；马来酸依那普利的回收率为１０１．２％（ｎ＝７），ＲＳＤ＝０．９％。

A HPLC method was developed for determination of two constituents in enalapril maleate composite tablets simultaneously. The chromatographic conditions were: column, Spherisorb C6H5, 5μm; mobil phase, methanol-0. 03 mol/L KH2PO4 (30 : 70, pH=4.0); internal standard, atenolol; detected at 205nm. The average recoveries (n=7) of hydrochlorothiazide and enalapril maleate were 99. 6% (RSD=0. 5%) and 101. 2% (RSD=0. 9%) respectively. The method is simple and accurate.