目的 建立測定阿伐斯汀膠囊溶出度的方法。方法 采用高效液相色譜法，色譜柱為Agilent Zorbax SB C₁₈色譜柱（150 mm×4.6 mm，5 μm）；流動相：乙腈-四氫呋喃-2%三乙胺（用50%磷酸調(diào)節(jié)pH值至6.9）（12：8：80）；檢測波長為307 nm；柱溫為40℃；體積流量為1.0 mL/min；進樣量為20 μL。溶出度測定采用槳法，以水為溶出介質(zhì)，溶出介質(zhì)體積為500 mL，轉(zhuǎn)速為50 r/min，20 min取樣。結(jié)果 阿伐斯汀在1.63~24.40 μg/mL與峰面積線性關(guān)系良好（r=1.000）；平均回收率為99.87%，RSD值為0.38%（n=9）。3批樣品的溶出度分別為98.00%、98.00%、96.00%（n=6）。結(jié)論 本方法準確可靠，簡單易行，專屬性強，適用于阿伐斯汀膠囊的溶出度測定。

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.