HPLC法检测瑞巴派特片体外溶出度

Development and Validation of dissolution in vitro for Rebamipide Tablets by HPLC

目的建立瑞巴派特片体外溶出度HPLC检测方法及方法学验证。方法溶出度试验采用桨法,转速50 r/min;以水、p H 1.2盐酸(含氯化钠)、p H6.0枸橼酸-磷酸二氢钠缓冲液和p H6.8磷酸缓冲液为溶出介质,HPLC法测定溶出量。结果瑞巴派特在5.533~221.334μg/m L内线性关系良好(r=0.999 9),专属性、精密度、准确度、溶液稳定性及耐用性等均良好。结论本方法简单方便,提高了瑞巴派特溶出度测定的专属性和准确性,可用于该制剂的质量控制。

Objective To establish and evaluate a method for determining the dissolution of Rebamipide Tablets in vitro. MethodsThe paddle method was used for the dissolution test and the rotation rate was set at 50 r/min. Useing water,pH 1.2 hydrochloric acid solution（containing sodium chloride）, pH 6.0 Citrate-sodium dihydrogen phosphate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. HPLC was used for the determination of dissolution quantity. Results There was a good linear relationship between the quality concentration of Rebamipide and peak area in the range of 5.533—221.334 μg/m L（r = 0.999 9）. Specificity, precision, accuracy, solution stability and durability were all good. Conclusion The HPLC method is simple,which improve the specificity and accuracy of dissolution determination for rebamipide tablets, and it can be used for the quality control of the preparation.