聚羟基乙醇酸中锡的无火焰原子吸收测定法研究

Determination of residual Sn level in poly L-lactic-co-glycolic acid by GF atomic absorption spectrophotmetry

目的 建立聚羟基乙醇酸辅料的锡 (Sn)含量测定方法。方法 样品经硫酸处理 ,干法马弗炉灰化 ,盐酸溶解 ,石墨炉原子吸收光谱法测定。抗坏血酸为基体改进剂。结果 线性范围为 1～ 10mg/L ;r =0 996 8;检出限为 0 2 3mg/L ;方法的平均回收率为 97 1% ;日内RSD为 6 9%。结论 该方法已符合 2 0 0 0年中国药典关于杂质限量检测方法的规定 。

Objective To establish a method for determination of Sn in poly L-lactic-co-glycolic acid pharmaceutical necessities. Metho ds The specimen was soaked by H 2SO 4 ,incinerated by the muffle ,diss olved by HCl and determined by GF-AAS. Vitamin C was used as a matrix modifier. Results The linear range was 1～10 mg/L;r= 0 996 8 ;The limit of detection was 0 23 mg/L;The ave rage recovery was 97 1% ; The intra-day precision of method was 6 9%. Conclusion The method meets the criterion of China Pharmacopoeia 2000 fo r detecting drug impurity and is feasible for the determination of Sn in poly L-lac tic-co-glycolic acid pharmaceutical necessities.