阿伐斯汀胶囊的溶出度研究

Dissolution of Acrivastine Capsules

目的建立测定阿伐斯汀胶囊溶出度的方法。方法采用高效液相色谱法,色谱柱为Agilent Zorbax SB C18色谱柱(150 mm×4.6 mm,5μm);流动相:乙腈–四氢呋喃–2%三乙胺(用50%磷酸调节p H值至6.9)(12∶8∶80);检测波长为307 nm;柱温为40℃;体积流量为1.0 m L/min;进样量为20μL。溶出度测定采用桨法,以水为溶出介质,溶出介质体积为500 m L,转速为50 r/min,20 min取样。结果阿伐斯汀在1.63~24.40μg/m L与峰面积线性关系良好(r=1.000);平均回收率为99.87%,RSD值为0.38%(n=9)。3批样品的溶出度分别为98.00%、98.00%、96.00%(n=6)。结论本方法准确可靠,简单易行,专属性强,适用于阿伐斯汀胶囊的溶出度测定。

Objective To establish a method for the dissolution of Acrivastine Capsules. Methods HPLC method was performed on Agilent ZORBAX SB C18 column（150 mm × 4.6 mm, 5 μm）. The mobile phase consisted of acetonitrile-tetrahdrofuran-2% triethylamine（adjust to pH 6.9 with 50% phosphoric acid）（12∶8∶80）. The detection wavelengths were 307 nm, column temperature was 40 ℃, flow rate was1.0 mL/min, and injection volume was 20 μL. The paddle method was used to determine the dissolution. Water was used as dissolution medium, medium volume was 500 mL, the rotating speed was 50 r/min, and samples were took after 20 min. Results The linear range of acrivastine was 1.63 — 24.40 μg/mL（r =1.000）. The average recovery was 99.87%（RSD = 0.38%, n = 9）. The accumulative dissolutions of 3 batches of samples were 98.00%, 98.00%, and 96.00%（n = 6）. Conclusion The method is accurate, simple, reproducible, and suitable for the determination of dissolution of Acrivastine Capsules.