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目的采用反相HPLC法测定复方醋酸甲地孕酮片中的邻苯二甲酸二丁酯(DBP)。方法采用Phenomenex Luna TC C18(2)色谱柱(250 mm×4.6 mm,5μm),以乙腈-水(75∶25)为流动相,流速1.0 mL·min-1,检测波长230 nm,柱温25℃,进样体积20μL。结果 1.88～15.04μg·mL-1DBP与峰面积呈良好的线性关系(r=0.9999);平均回收率为95.5%,RSD=0.57%(n=9)。结论所用方法操作简便、灵敏度高、重复性好,可准确地测定复方醋酸甲地孕酮片中的DBP。
Objective To determine the content of dibutyl phthalate (DBP) in megestrol acetate mesylate tablets by reverse phase HPLC. Methods The mobile phase consisted of Phenomenex Luna TC C18 (2) column (250 mm × 4.6 mm, 5 μm) with acetonitrile-water (75:25) as mobile phase at a flow rate of 1.0 mL · min- ℃, injection volume 20μL. Results 1.88 ~ 15.04μg · mL-1 DBP showed a good linear relationship with the peak area (r = 0.9999). The average recovery was 95.5% and RSD was 0.57% (n = 9). Conclusion The method used is simple, sensitive, reproducible and accurate for the determination of DBP in megestrol acetate tablets.