HPLC法测定盐酸氟哌噻吨含量

Content Determination of Flupentixol Dihydrochloride by HPLC

目的建立测定盐酸氟哌噻吨含量的方法。方法采用Eclipse C18柱(XDB-C18,4.6mm×250mm,5μm),以磷酸盐缓冲液(取磷酸二氢钾1.74g、磷酸氢二钠0.15g,加水溶解并稀释至1000m L,用1mol·L^(-1)氢氧化钠或磷酸调pH至6.5。再加四庚基溴化铵0.22g和20m L甲醇)为流动相A,以甲醇-乙腈(63∶17)为流动相B,以流动相A-流动相B(20∶80)为系统流动相;检测波长为230nm;柱温为35℃;流速为1.0m L·min^(-1);进样量20μL。结果盐酸氟哌噻吨在6.001μg·m L^(-1)~32.003μg·m L^(-1)(r=0.9995)范围内呈良好的线性关系,且精密度、稳定性、耐用性等均满足要求。结论本方法准确,灵敏度高,可用于盐酸氟哌噻吨含量测定。

OBJECTIVE To establish a method for the content determination of Flupentixol Dihydrochloride.METHODS The determined condition of HPLC was performed on an Eclipse XDB-C18column（ 4. 6mm × 250 mm,5μm）. The mobile phase was consisted of the mobile phase A of phosphate buffer（ added 1. 74 g of potassium dihydrogen phosphate,0. 15 g of disodium hydrogen phosphate dodecahydrate to 1L of water,adjusting to pH with 10mol·L- 1potassium hydroxide or phosphoric acid,then added 0. 22 g of etramethylammonium bromide and 20 m L of methanol）-the mobile phase B of methanol： acetonitrile（ 63 ∶ 17）（ 20 ∶ 80） at a flow rate of 1. 0 m L·min^（-1）. The detection wavele ngth was set at 230 nm. The temperature of the column was 35℃,and the injection volume was20μL. RESULTS Flupentixol Dihydrochloride showed a good linear relation ship in 6. 001μg·m L^（-1）~ 32. 003μg·m L^（-1）（ r = 0. 9998）. And the accuracy precision、stability and durability can meet the specific analytical requirements. CONCLUSION The method is specific,accurate and sensitive,which can be used for the determination of Flupentixol Dihydrochloride bulk drug.