颠茄磺苄啶片溶出度测定方法研究

目的:建立测定颠茄磺苄啶片溶出度的方法.方法:采用HPLC法测定颠茄磺苄啶片的溶出度,采用XDB-C18色谱柱(4.6 mm×150 mm,5μm),以乙腈-水-三乙胺(20:80:0.2,v/v/v)用冰醋酸调节pH值到6.0为流动相,流速为1.2 ml/min,检测波长为240 nm,柱温为30℃.结果:磺胺甲噁唑浓度在40.0～400.0 μg/ml范围内与吸收度线性关系良好,r=0.999 7(n=6),平均回收率为98.7%;RSD为1.1%;甲氧苄啶浓度在8.0～80.0 μg/ml范围内与吸收度线性关系良好,r=0.999 8(n=6),平均回收率为99.1%,RSD为1.0%.结论:该方法灵敏、结果可靠、重现性好,可用于颠茄磺苄啶片的溶出度测定.

Study on dissolution determination of Belladonna Sulfamethoxazle and Trimethoprim Tablets

Objective: To establish a method for determining the dissolution of Belladonna Sulfamethoxazle and Trimetho-prim tablets. Methods: The dissolution of Belladonna Sulfamethoxazle and Trimethoprim Tablets was determined by HPLC. The separation was performed on a XDB-C18 column(4.6 mm×150 mm, 5 μm), the mobile phase was acetonitrile-water-triethylamine(20:80:0.2, v/v/v, adjusted pH with acetic acid to 6.0) with a flow rate of 1.2 ml/min, the detection wave-length was set at 240 nm, the column temperature was 30℃. Results: The linear range of Sulfamethoxazle was 40.0-400.0 μg/ml(r=0.999 7), the average recovery rate was 98.7% with a RSD of 1.1%. The linear range of Trimethoprim was 8.0-80.0 μg/ml(r=0.999 8), the average recovery rate was 99.1% with a RSD of 1.0%. Conclusion: The method is sen-sitive, accurate, reliable and suitable for determining the dissolution of Belladonna Sulfamethoxazle and Tfimethoprim Tablets.