盐酸贝那普利片溶出度测定方法的研究

Research on determination of the dissolution of Benazepril Hydrochloride tablets

目的建立盐酸贝那普利片〔1〕溶出度测定方法。方法色谱柱为Welch Materials C18柱(4.6mm×250mm,5μm),流动相为甲醇-四丁基溴化铵溶液(取四丁基溴化铵0.81g,加水360mL使溶解,加冰醋酸0.2mL,摇匀)(68:32);流速:1.0mL.min-1;检测波长为240nm。结果在3.924μg.mL-1～39.24μg.mL-1浓度范围内与峰面积呈良好的线性关系,平均回收率为99.2%,RSD为0.5%(n=9)。结论该方法操作简便、准确可靠。

OBJECTIVE To establish a method for determination of the dissolution of Benazepril Hydrochloride tablets.METHODS The analytical column was Welch Materials C18 column（4.6mm×250mm,5μm）and the mobile phase was methanol-tetrabutylammonium bromide solution（68∶ 32） at a flow rate of 1.0mL·min-1.The UV detection wavelength was at 240nm.RESULTS The linearity was good for benazepril hydrochloride within the range of 3.924μg·mL-1~39.24μg·mL-1（r=1.000）,the mean recovery was 99.2%（n=5）,RSD=0.5%;CONCLUSION The method is simple,accurate and precise.