RP-HPLC法测定贝那普利氢氯噻嗪片的含量

Determination of Benazepril Hydrochloride and Hydrochlorothiazide Tablets by RP-HPLC

目的：建立高效液相色谱法测定贝那普利氢氯噻嗪片的含量。方法采用 Ultimate AQ-C18柱（250 mm ×4．6 mm ，5μm）；以四氢呋喃-水-冰醋酸（250 mL ＋750 mL ＋4 mL 加入四丁基溴化铵1．0 g）为流动相，检测波长：240 nm ；流速：1．5 mL·min -1。结果盐酸贝那普利质量浓度在41．2～412．3μg·mL -1范围内呈线性，r＝0．9995，氢氯噻嗪质量浓度在51．0～509．6μg·mL -1范围内呈线性，r＝0．9998；盐酸贝那普利平均回收率在99．6％～101．6％之间，RSD 小于2％，氢氯噻嗪平均回收率在99．3％～100．7％之间，RSD 小于2％。结论该方法操作简便、准确、灵敏、重复性好，可用于贝那普利氢氯噻嗪片的质量控制。

Objective To establish an HPLC method for the determination of Benazepril Hydrochloride and Hydrochlorothiazide Tablets .Methods The chromatographic conditions were as follows ：Ultimate AQ-C18 column （250 mm × 4 .6 mm 5 μm） ,mobile phase of butylene oxide-water-glacial acetic acid （250 mL ＋ 750 mL ＋ 4 mL ,add tetrabutylammonium bromide 1 .0 g ） ,detection wavelength at 240 nm ,and flow rate 1 .5 mL ？ min - 1 .Results The calibration curve of benazepril hydrochloride was linear in the range of 41 .2-412 .3 μg ？ mL - 1 ,r= 0 .999 5 ,while hydrochlorothiazide in the range of 51 .0-509 .6 μg ？ mL - 1 ,r= 0 .999 8 .The average recovery of benazepril hydrochloride was between 99 .6% -101 .6% ,RSD 〈 2% .The average recovery of hydrochlorothiaz-ide was between 99 .3% -100 .7% ,RSD 〈 2% .Conclusion This method is simple ,accurate and reliable for the quality control of Benazepril Hydrochloride and Hydrochlorothiazide Tablets .