高效液相色谱法测定贝那普利氢氯噻嗪片的溶出度

Determination of the dissolution of benazepril hydrochloride and hydrochlorothiazide tablets by HPLC

采用篮法,以0.1 mol/L盐酸为溶出介质,温度37 ±0.5℃,转速1OOr/min,取样时间为30min;采用C1s（250×4.6mm,5μm）色谱柱,以四氢呋喃-水-冰醋酸（25∶ 75∶ 0.4）为流动相,流速1.0 mL/min,柱温25℃,建立反相高效液相色谱法同时测定贝那普利、氢氯噻嗪的溶出度.结果表明,氢氯噻嗪和贝那普利的线性范围分别为0.999 2～ 14.99μg/mL（r=0.999 7）和0.798 4～9.581 μg/mL（r=0.999 6）,平均回收率分别为99.9％和100.2％.方法简便、准确,专属性强,可有效测定贝那普利氢氯噻嗪片的溶出度.

The rotating basket method was used to determine the dissolution of benazepril and hydrochlorothiazide tablets with 0.1mol/L hydrochloric acid as dissolution medium at the rotating speed of 100 r/min.And the dissolved samples were determined by HPLC every 30min,using C18 （250 ×4.6mm,5μm） column and tetrahydrofuran-water-acetic acid glacial （25 ∶ 75 ∶ 0.4） as mobile phase.The flow rate was set at 1.0 mL/min.The column temperature was set at 25 ℃.The calibration curves for hydrochlorothiazide and benazepril were good linear in the range of 0.999 2 ～ 14.99μg/mL （r =0.999 7） and 0.798 4 ～ 9.581 μg/mL （r =0.999 6）,the average recoveries were 99.9％ and 100.2％,respectively.The dissolutions of benazepril and hydrochlorothiazide were determined simultaneously.This method was simple and accurate.The results were reliable so that it could be used to determine the dissolution of benazepril hydrochloride and hydrochlorothiazide tablets for quality control of pharmaceutical preparations.