摘要
目的建立一种快速、简便和准确的高效液相色谱法,用于测定艾拉莫德片的有关物质。方法使用Agilent HC-C18色谱柱（250 mm×4.6 mm,5μm）,乙腈-50 mmol·L-1磷酸二氢钾溶液（体积分数50%磷酸溶液调节pH值至3.0）（体积比10∶90）作为流动相,流速1.0 mL·min-1,检测波长为270 nm,柱温25℃。结果方法学研究结果表明,片剂辅料对艾拉莫德有关物质的测定没有干扰;杂质1和杂质2质量浓度均在5.0~50 mg·L-1内与峰面积呈良好的线性关系（r=0.999 6和0.999 8）;平均回收率分别为99.77%和99.89%,RSD分别为1.3%和1.0%（n=9）。经测定艾拉莫德片中2种主要杂质的总含量为0.107%。结论所建立的艾拉莫德片有关物质测定方法,简单可靠、准确有效,为艾拉莫德片有关物质检测提供了参考方法。
Objective To establish an high performance liquid chromatography （HPLC）to determine impurity 1 and impurity 2 in iguratimod tablets. Methods Agilent HC- C18 chromatographic column （250 mm× 4. 6 mm, 5 μm） was used, and acetonitrile- 50 mmol- L - 1 of potassium dihydrogen phosphate solution （50% phosphoric acid to adjust pH value to 3.0） （ V： V = 10： 90） was chosen as mobile phase,the flow rate was 1.0 mL- min - 1, detection wavelength was 270 nm, column temperature was 25 ℃. Results Impurity 1 and impurity 2 in this test were in the concentration of 5.0-50 mg. L -1 with good linear relationship （r = 0. 999 6 and 0. 999 8 ） ; the average recoveries were 99.77% and 99.89%, respectively ; RSD were 1.3% and 1.0% （n = 9 ）. Conclusions This method is simple ,rapid and accurate, and is suitable for the simultaneous determination of impurity 1 and impurity 2 in iguratimod tablets. Iguratimod tablets is carried out on the domestic content determination of related material to provide relevant quality control method.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2014年第9期711-714,共4页
Journal of Shenyang Pharmaceutical University
作者简介
史玉红（1971-），女（汉族），辽宁沈阳人，副主任药师，主要从事临床药学的研究，Tel．13386870728，E-mail1979289315@qq．com。
