摘要
目的:建立盐酸拉贝洛尔注射液含量测定及有关物质的检查方法。方法:采用高效液相色谱法。色谱柱为AgilentTC-C18,流动相为甲醇-0.1mol/L磷酸二氢钠溶液(55:45),流速为1.0ml/min,柱温为50℃,检测波长为230nm。结果:盐酸拉贝洛尔峰与游离羧酸峰及强制破坏产生的降解产物峰均分离良好,盐酸拉贝洛尔检测质量浓度线性范围为41.40～372.60μg/m(lr=1.0000),平均回收率为99.97%(RSD=0.64%,n=9),检测限为52.54ng/ml。结论:该法操作简单、快速、专属性强、结果准确。
OBJECTIVE：To establish a method to determine the content and related substances of Labetalol hydrochloride injection.METHODS：HPLC was used.The determination was carried out using Agilent TC-C 18 column and methanol-0.1 mol/L sodium dihydrogen phosphate（55：45）as mobile phase at the flow rate of 1.0 ml/min.The column temperature was 50 ℃,and the detection wavelength was 230 nm.RESULTS：The resolution between the peaks of labetalol hydrochloride and free carboxylic acid and other peaks of acid degradation products was good.The linear range of labetalol hydrochloride were 41.40-372.60 μg/ml（r=1.000 0） with average recovery of 99.97%（RSD=0.64%,n=9）.The limit of detection was 52.54 ng/ml.CONCLUSIONS：The method is simple,rapid,specific and accurate.
出处
《中国药房》
CAS
CSCD
2013年第9期832-834,共3页
China Pharmacy
