气相色谱-质谱法测定硫酸亚铁缓释片中邻苯二甲酸二辛酯含量

目的建立检测硫酸亚铁缓释片中邻苯二甲酸二辛酯(DOP)含量的气相色谱-质谱法。方法采用HP-5MS色谱柱(30 m×0.25 mm,0.25μm),进样口温度250℃;程序升温,初始60℃,保持1 min,以20℃/min升至220℃,保持1 min,再以5℃/min升至300℃,保持7 min。结果 DOP进样量在0.79～7.9 ng范围内总离子流峰面积线性关系良好,回归方程为Y=3×106X+99 132(r=0.998 1),平均回收率为95.0%,RSD=2.3%(n=6)。结论 5批样品测定结果表明,该方法灵敏度高,结果准确可靠,适用于硫酸亚铁缓释片中DOP含量的检测。

Quantitative Determination of Dioctyl Phthalate in Ferrous Sulfate Sustained Release Tablets by GC- MS

Objective To establish a GC-MS method for the quantitative determination of dioctyl phthalate（DOP） in Ferrous Sulfate Sustained Release Tablets. Method DOP was determined on the HP-SMS chromatographic column（30 m ×0. 25 mm, 0. 25 μm）. The intlet temperature was 250℃. The temperature programming started at 60 ℃, holding for 1 rain, then increased at 220 ℃ at a rate of 20 ℃/min, hohting for 1 min, and then increased at 300 ℃ at a rate of 5 ℃/min, holding for 7 rain. Results DOP had a good linear relationship in 0. 79 -7.9 ng with the linear regression equation of Y=3 ×10^6 ＋99 132（ r =0. 998 1）. The average recovery rate was 95.0% with RSD = 2.3% （n =6）. Conclusion The determination results in 5 batches of samples show that this method is highly sen- sitive, accurate and reliable in the detection results, and suitable for detecting the DOP content in Ferrous Sulfate Sustained Release Tablets.