【摘要】 建立多潘立酮凝胶剂含量测定及有关物质检查的HPLC方法。采用Inertsil(ODS-3色谱柱,以甲醇-0.5%醋酸铵(70∶30)为流动相,检测波长为287nm,流速为1.0mL·min-1,柱温为35℃。多潘立酮与其相邻杂质峰能完全分离,多潘立酮在10.0~100.0μg·mL-1浓度范围内线性关系良好,r=0.9999,平均回收率为101.0%,RSD=1.1%(n=9)。本方法准确可靠,专属性好,可用于多潘立酮凝胶的含量测定及有关物质检查。更多还原

【Abstract】 A HPLC method was established for determination of domperidone and its related substances from gel dosage form. InertsilR ODS-3 column was used with methanol -0.1% w/v aqueous ammonium acetate buffer (70∶30, v/v) as mobile phase. The flow rate was 1.0 mL·min-1, column temperature was set at 35 ℃ and detecting wavelength was set at 287 nm. The peak of domperidone was completely separated with other impurity peaks. Calibration of domperidone was performed over the range of 10.0-100.0 μg·mL-1 (r=0.9999). The average recovery rate was 101.0 % and RSD was 1.1 % (n=9). This method was accurate, reliable and specific. It can be used for determination of domperidone gel and related substances.更多还原