HPLC测定复方醋酸甲地孕酮片中的邻苯二甲酸酯类塑化剂

Determination of phthalate plasticizers in Compound megestrol acetate tablets by HPLC

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 develop an RP - HPLC method for the content determination of dibutyl phthalate（DBP） in Compound megestrol acetate tablets. METHODS An Phenomenex Luna TC C 18 （2）column（ 250 mm × 4.6 mm, 5 μm）was used with a mobile phase of acetonitrile -water（75 ： 25）. The flow rate was 1.0 mL·min^-1, and the detection wavelength was 230 nm. The column temperature was 25 ℃ ,and the volume of injection was 20 μL. RELUSTS A good linear correlation of DBP was observed within the range of 1.88 - 15.04 μg·mL- l （ r = 0. 9999 ）. The average recovery was 95.5 % with RSD of 0.57% （ n = 9）. CONCLUSION The method is simple, sensitive and repeatable, it can determine accurately the content of DBP in Compound megestrol acetate tablets.