盐酸曲马多片溶出度测定

Tramadol hydrochloride tablets dissolution of determination

目的建立盐酸曲马多片溶出度测定方法。方法以0.01 mol/L盐酸为溶出介质,采用高效液相色谱法测定其溶出度。结果本高效液相色谱法测定盐酸曲马多的质量浓度10.173-1017.3μg/ml内呈良好的线性相关性,相关系数r=0.999 9,平均回收率为99.89%（RSD=1.12%,n=6）,溶出度符合规定。结论该方法准确、可靠、简便、易行,可作为制剂的溶出度测定方法。

Objective To establish the method of dissolution of the determination for tramadol hydrochloride tablets. Methods The dissolution rates were determined by HPLC,0. 01 mol/L hydrochloride acid as dissolution medium was used. Results The linear range of tramadol hydrochloride was 10. 173 - 1017. 3 μg/ ml （r = 0. 999 9）. The average recovery of tramadol hydrochloride was 99. 89% （RSD = 1.12%, n = 6）, The resuit of dissolution of the tablets meet the requirement. Conclusion An accurate , simple , rapid , qualitative method with good reproducibility to determine dissolution of tramadol hydrochloride tablets is established.