盐酸洛美利嗪胶囊溶出度研究

目的建立盐酸洛美利嗪胶囊的溶出度测定方法。方法采用桨法,以0.1 mol/L的盐酸溶液为溶出介质,转速为50 r/min,采用反相高效液相色谱法测定。结果盐酸洛美利嗪质量浓度在1.0～12.0μg/mL范围内与峰面积呈良好线性关系(r=0.999 3),平均回收率为99.6%,RSD=1.2%;盐酸洛美利嗪在45 min时平均溶出量均大于75%,且均一性较好。结论该方法快速、简便,结果准确、可靠,重复性好。

Study on Dissolution of Lomerizine Hydrochloride Capsule

Objective To establish a method for the dissolution determination of Lomerizine Hydrochloride Capsule. Methods The paddle method was adopted. With 0. 1 mol/L hydrochloric acid solution as the solvent,the rotation speed was set at 50 r/min,the RP-HPLC method was used to determine the content of lomerizine hydrochloride. Results The mass concentration of lomerizine hydrochloride in the range of 1.0- 12.0 μg/mL showed the good linear relation with the peak area（r=0. 999 3）and the average recovery rate of lom- erizine hydrochloride was 99.6% （RSD = 1.2% ）. The average dissolution of lomerizine hydrochloride was above 75% at 45 rain,with good uniformity. Conclusion This method is rapid and simple with accurate and reliable results and good reproducibility.