论文部分内容阅读
目的研究改进马来酸氯苯那敏片的溶出度检查方法。方法采用水900 ml为溶出介质,50 r·min~(-1),15min取样;Agilent ZORBAX SB-C18(4.6 mm×150 mm)色谱柱,0.5%三乙胺溶液(磷酸调节pH 4.0)-乙腈-甲醇(68∶23.8∶8.2)为流动相,流速1.0 ml·min~(-1),柱温:40℃,检测波长262 nm。结果马来酸氯苯那敏浓度在1.0952~10.9520μg·ml~(-1)范围内与峰面积呈良好的线性关系,回归方程为Y=57.872 X-27.957(r=0.9996,n=6),平均回收率为101.10%,RSD=1.56%,n=9。按照《医疗用药品品质情报集》限度为15 min溶出标示量的80%为标准,样品的不合格率为33.33%。结论改进的方法简便易行,准确度高,重复性好,可用于该制剂的质量控制。
Objective To study the dissolution testing method for improving chlorphenamine maleate tablets. Methods 900 ml of water was used as the dissolution medium and the samples were collected at 50 r · min -1 for 15 min. The samples were separated on an Agilent ZORBAX SB-C18 column (4.6 mm × 150 mm) with 0.5% triethylamine (pH 4.0) Acetonitrile-methanol (68:23.8:8.2) as mobile phase at a flow rate of 1.0 ml · min -1 .The column temperature was 40 ℃ and the detection wavelength was 262 nm. Results The concentration of chlorpheniramine maleate in the range of 1.0952 ~ 10.9520μg · ml ~ (-1) showed a good linear relationship with the peak area. The regression equation was Y = 57.872 X-27.957 (r = 0.9996, n = 6) , The average recovery was 101.10%, RSD = 1.56%, n = 9. According to “Medical Information Quality Intelligence Set” limit of 15 min dissolution of 80% of the standard amount as the standard, the sample failed rate of 33.33%. Conclusion The improved method is simple, accurate, reproducible and can be used for the quality control of the preparation.