论文部分内容阅读
目的:建立口服固体制剂中邻苯二甲酸酯类化合物的测定方法。方法:采用甲醇提取,过滤,DB-5MS色谱柱(30 m×0.25 mm×0.25μm),氦气为载气,流速1.0 mL.min-1,GC-MS联用法检测,检测方式为SCAN和SIR。结果:实验条件下,20种邻苯二甲酸酯类能很好分离检测,各组分的检出限均大于2μg.g-1,线性范围均在2～40μg.mL-1之间,相关系数均大于0.99,RSD均小于10%,加标回收率在79%～99%之间。结论:本法对色谱柱和仪器污染小,进样残留少,可同时测定口服固体制剂中的20种邻苯二甲酸酯类化合物。
Objective: To establish a method for the determination of phthalates in oral solid preparations. Methods: Methanol extraction, filtration, DB-5MS column (30 m × 0.25 mm × 0.25 μm), helium carrier gas, flow rate 1.0 mL.min-1, GC- SIR. Results: Under the experimental conditions, 20 kinds of phthalates can be well separated and detected. The detection limits of each component are more than 2μg.g-1, and the linear range is between 2 ~ 40μg.mL-1 The coefficients were greater than 0.99, RSD was less than 10%, and the spiked recoveries ranged from 79% to 99%. Conclusion: This method has the advantages of less pollution to column and instrument, less sample residue and simultaneous determination of 20 phthalates in oral solid preparations.