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目的:建立依巴斯汀分散片溶出度测定方法。方法:参照《中国药典》2005年版二部溶出度测定法第二法,以0.1mol·L~(-1)盐酸溶液为溶出介质,20min取样,采用UV法在258nm处测定吸光度,计算溶出量。结果:依巴斯汀在3.84～14.53μg·ml~(-1)范围内溶液浓度与吸光度呈良好线性关系(r=0.9999);平均回收率为99.1%(n=9,RSD为0.8%);测定溶液在8h内稳定;样品的溶出均一性良好,RSD为3.4%～5.8%,20 min时平均累积溶出率为80.0%～86.1%。结论:该方法简便易行,准确可靠,可用于依巴斯汀分散片溶出度测定。
Objective: To establish a method for the dissolution of ebastine dispersible tablets. Methods: According to the second method of Dissolution Test of Chinese Pharmacopoeia (2005 edition), 0.1mol·L ~ (-1) hydrochloric acid solution was used as dissolution medium for 20min. The absorbance was measured by UV method at 258nm. . Results: The ebastine showed good linearity (r = 0.9999) between the concentration and the absorbance of 3.84 ~ 14.53μg · ml ~ (-1); the average recovery was 99.1% (n = 9, RSD 0.8% ; The solution was stable within 8h; the dissolution of the sample was good, RSD was 3.4% ~ 5.8%, and the average cumulative dissolution rate was 80.0% ~ 86.1% at 20 minutes. Conclusion: The method is simple, accurate and reliable, and can be used for the determination of elution of ebastine dispersible tablets.