盐酸索他洛尔片的含量测定及稳定性考察

DETERMINATION OF SOTALOL HYDROCHLORIDE TABLETS

目的 :研究盐酸索他洛尔片的质量标准及其稳定性。方法 :样品用 0 .1mol/L盐酸溶解 ,经过滤后测定。紫外分光光度法的测定波长为 2 2 8nm ;高效液相色谱法采用ODSC18柱 ,以 0 .1%HAc 乙腈(80 :2 0 )为流动相 ,磺胺二甲基嘧啶为内标物 ,检测波长为 2 2 8nm。结果 :紫外分光光度法的线性范围为 5～2 5mg/mL(r =0 .9999) ,平均回收率为 99 4 7% (n =9,RSD =0 .87% ) ;高效液相色谱法的线性范围为 5～4 5mg/L(r =0 .9997) ,平均回收率为 99 0 1% (n =9,RSD =0 .77% )。 结论 :这两种方法用于测定盐酸索他洛尔片的含量考察稳定性具有准确、精密、简便的特点。

Objective:To study on the quality and the stability of sotalol hydrochloride tablets.Methods:The powder of sample was dissolved in 0.1mol/L HCL solution,and then was filtered.The portion of the filtrate was determined by the UV method and the HPLC method respectively.The detection wavelength was set at 228nm.The chromatographic conditions were ODS C 18 column as stationary phase,0.1%HAc acetonitril(80:20) as mobile phase at a flow rate 1.5ml/min,and sulfamethazine as an internal standard.Results:To the UV method,the linear range was 5～25mg/L(r=0.9999),and the recovery was 99.47%(n=9).To the HPLC,the linear range was 5～45mg/L(r=0.9997),the recovery was 99.01%(n=9).Conclusion:None of excipients in the tablets interfered with the determination of sotalol hydrochloride by the UV method and the HPLC method.The methods are simple and accurate for assaying the tablets.