复方阿苯达唑混悬液溶出条件的测定

Determination of dissolution conditions of compound albendazole suspension

为了建立具有区分复方阿苯达唑混悬液中阿苯达唑和羟氯扎胺溶出度的方法,采用Agilent Eclipse XDB-C18(150 mm×4.6 mm,3.5μm)色谱柱,以含0.1%磷酸的10 mmol/mL磷酸二氢铵与甲醇的液相体积比为20∶80为流动相,检测波长300 nm,流速1.0 mL/min,柱温35℃。通过筛选不同pH值的缓冲液及含不同浓度表面活性剂的溶出介质,绘制本品中阿苯达唑和羟氯扎胺的体外溶出曲线,溶出方法为桨法,转速为50 r/min。结果显示,阿苯达唑和羟氯扎胺的质量浓度在10~100μg/mL范围内与检测峰面积呈良好的线性关系,其平均回收率(n=9)分别为99.1%和98.4%。本试验结果证明,分别以pH=1.5的盐酸溶液和含0.01%十二烷基硫酸钠的pH=7.4的磷酸盐缓冲液为双溶出介质时,阿苯达唑和羟氯扎胺能获得具有适当区分度的溶出曲线。

In order to establish a method to differentiate the dissolution rate of albendazole and oxyclozanide in a compound albendazole suspension,an Agilent Eclipse XDB-C18 column(150 mm×4.6 mm,3.5μm)was used with a mobile phase of 10 mmol/mL ammonium dihydrogen phosphate containing 0.1%phosphoric acid and methanol in a liquid phase volume ratio of 20∶80,a detection wavelength of 300 nm,flow rate of 1.0 mL/min,and column temperature of 35℃.The in vitro dissolution curves of albendazole and oxyclozanide in this product were determined by screening the different pH buffers and dissolution media containing different concentrations of surfactants,and the dissolution method was a paddle method with a speed of 50 r/min.The results showed that concentration of albendazole-oxyclozanide showed good linearity in the range 10-100μg/mL with the detection peak area,and their mean recovery rates(n=9)were 99.1%and 98.4%,respectively.This test demonstrated that dissolution profiles with appropriate differentiation were obtained for albendazole and oxyclozanide when a hydrochloric acid solution at pH=1.5 and a phosphate buffer at pH=7.4 containing 0.01%sodium dodecyl sulfate,respectively,were used as double dissolution media.