复方氯丙那林溴己新胶囊溶出度测定方法的建立

Development of the Dissolution Method for Compound Clorprenaline Bromhexine Capsules

目的建立复方氯丙那林溴己新胶囊溶出度测定方法。方法篮法,100 r·min^(-1),溶出介质为含0.2%十二烷基硫酸钠的0.1 mol·L^(-1)盐酸溶液900 mL,45 min取样,HPLC法测定,限度均为标示量的75%。结果新建立的溶出度检查方法,盐酸氯丙那林在0.57~8.00μg·mL^(-1)范围内,盐酸溴己新在1.13~15.82μg·mL^(-1)范围内,盐酸去氯羟嗪在2.81~39.31μg·mL^(-1)范围内,与峰面积均有良好的线性关系。盐酸氯丙那林平均回收率为99.5%(RSD=0.4%,n=9),盐酸溴己新平均回收率为101.1%(RSD=0.4%,n=9),盐酸去氯羟嗪平均回收率为99.8%(RSD=0.5%,n=9)。三个组分准确度均高,4批样品在45 min是平均溶出量均在75%以上并且有较好的均一性。结论方法快速、简便,结果准确可靠,重现性好。

OBJECTIVE To develop a new dissolution method of Compound clorprenaline bromhexine capsules.METHODS Apparatus 1 was used with 100 r·min^(-1),the dissolutive medium was 0.1 mol·L^(-1) hydrochloric acid containing 0.2%SDS 900 mL,the dissolutive solution was taken and analyzed by HPLC when 45 minutes and the limpitation all were 75%in the new method for dissolution test.RESULTS The new method of dissolution test showed that clorprenaline hydrochloride was in the range of 0.57-8.00μg·mL^(-1),bromhexine hydrochloride was in the range of 1.13^(-1)5.82μg·mL^(-1),and decloxizine hydrochloride was in the range of 2.81-39.31μg·mL^(-1) with a good linear relationship with peak area.The average recovery rate of clorprenaline hydrochloride,bromhexine hydrochloride and decloxizine hydrochloride were 99.5%(RSD=0.4%,n=9),101.1%(RSD=0.4%,n=9),and 99.8%(RSD=0.5%,n=9),respectively.The accuracy of the three components was high,and the dissolution of Compound clorprenaline bromhexine capsules from four batches were over 75%.CONCLUSION The method is simple and rapid,the results are accurate and repoducible.