顶空气相色谱法测定盐酸依匹斯汀中溶剂残留

Determination of Solvent Residual in Epinastine Hydrochloride by Headspace Gas Chromatography

建立顶空气相色谱法分析盐酸依匹斯汀中溶剂残留。采用DB - 1大口径毛细管柱 ,以正丙醇为内标进行定量。甲醇、乙醚、三氯甲烷、四氢呋喃的线性范围分别为 7 9～ 317 0 μg·ml-1(r =0 9996 ) ,0 7～ 35 5 μg·ml-1(r=0 9998) ,1 5～ 73 5 μg·ml-1(r =0 9992 ) ,0 9～ 4 4 4 μg·ml-1(r =0 9994 ) ,回收率分别为 10 1 6 4% ,97 18% ,99 32 % ,10 1 12 % ,RSD分别为 1 97% ,1 10 % ,2 4 0 % ,0 84 %。本方法简单、准确、灵敏度高、重现性好。

A headspace gas chromatography method for the determination of solvent residual in epinastine hydrochloride was established. A DB-1 wide bore capillary column was used with n-propanol as internal standard. The linear range for methanol, ether, chloroform and tetrahydrofuran was 7 9～317 0μg·ml -1 (r=0 9996), 0 7～35 5μg·ml -1 (r=0 9998), 1 5～73 5μg·ml -1 (r=0 9992) and 0 9～44 4μg·ml -1 (r=0 9994) respectively. The recovery rate and RSD were 101 64% and 1 97%, 97 18% and 1 10%, 99 32% and 2 40%, 101 12% and 0 84% respectively. The method was simple, accurate, sensitive and repeatable.