高效液相色谱法测定盐酸决奈达隆片的溶出度  

Determination of Dissolution of Dronedarone Hydrochloride Tablets by HPLC

作　　者：金鹏飞[1] 夏路风[1] 邹定[1] 吴学军[1] 姜文清[1] 胡欣[1] 

机构地区：[1]卫生部北京医院药学部,北京100730

出　　处：《医药导报》2013年第10期1344-1347,共4页Herald of Medicine

基　　金：中央保健科研课题专项资金资助项目(B2009B032)

摘　　要：目的应用高效液相色谱技术建立盐酸决奈达隆片溶出度的测定方法。方法采用AgilentZORBAXEclipsePlusC18色谱柱（100mm×4．6mm，3．5μm）进行分离，以2mmol·L^-1磷酸二氢钠（氢氧化钠调至pH7．0）-甲醇-乙腈（20：30：50）为流动相，流速1．5mL·min^-1，检测波长290nm。溶出度采用浆法，以水900mL为溶出介质，转速125r·min^-1。结果辅料不干扰决奈达隆的坝4定；决奈达隆的线性相关系数（r）为1．0000；检出限（以决奈达隆游离碱计）为0．19mg·L^-1；精密度和12h稳定性RSD均〈1％；回收率101．2％-102．1％。3批样品溶出度的均-性良好（RSD〈7％），平均溶出度均〉75％。结论该方法准确、简单、快速，可作为盐酸决奈达隆片溶出度的测定方法。Objective To establish a high performance liquid chromatography （HPLC） method for determination of dissolution of dronedarone hydrocbloride tablets. Methods An Agi!ent ZORBAX Eclipse Plus C18 column （100 mm× 4.6 mm,3.5 μm） was used for the separation,with 2 mmol · L^-1 sodium dihydrogen phosphate （pH was adjusted to 7.0 with NaOH）-methanol-acetonitrile （20 ： 30 ： 50） as the mobile phase at the flow rate of 1.5 mL · min^-1. The detection wavelength was 290 nm. Paddle method was used in the dissolution test with 900 mL of water as the medium at the rotation speed of 125 r · min^-1 , and the sampling time was 60 min. Results The excipients did not interfere with the analysis of dronedarone;the correlation coefficient （r） was 1. 000 0 ;the lower limit of detection （LOD） was 0.19 mg · L^-1（ as dronedarone） ;the precisions and 12-hour stability were satisfactory with all RSD below 1% ; the spiked recovery ranged from 101.2% to 102.1%. The dissolution tests indicated good repeatability from 3 batches of samples with RSD all below 7 % , and the average dissolutions were all above 75%. Conclusion This method is accurate,fast and simple,and can be used for the determination of dissolution of dronedarone hydrochloride tablets.

关 键 词：决奈达隆 溶出度 色谱法 高效液相 

分 类 号：R972.2[医药卫生—药品] R927.2[医药卫生—药学]