| 引用本文: | 郑飞,华国栋.HPLC测定奥格列汀中基因毒性杂质残留量[J].中国现代应用药学,2017,34(3):396-398. |
| ZHENG Fei,HUA Guodong.Determination of Genotoxic Impurities in Omarigliptin by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(3):396-398. |
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| 摘要: |
| 目的 建立奥格列汀原料药中基因毒性杂质的HPLC测定方法。方法 采用Zorbax SB-C18色谱柱（250 mm×4.6 mm，5μm），进样量：20 μl；流动相为0.1%乙酸水-乙腈（65：35）；流速为1mL·min-1；紫外检测器，检测波长为220 nm；柱温为25℃，色谱乙腈为溶剂。结果 该方法专属性良好，测得苯磺酸异丙酯在4~60 μg·mL-1内线性关系良好，平均回收率为98.56%（n=9，RSD=3.78%），溶液在8 h内稳定。结论 该法操作简便，重复性好，结果准确可靠，可用于奥格列汀原料药中基因毒性杂质的测定。 |
| 关键词: 奥格列汀 原料药 基因毒性杂质 苯磺酸异丙酯 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.03.020 |
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| Determination of Genotoxic Impurities in Omarigliptin by HPLC |
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ZHENG Fei, HUA Guodong
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Department of Pharmacy, Dongfang Hospital of Beijing University of TCM, Beijing 100078, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method to determine genotoxic impurities in omarigliptin bulk drug. METHODS The HPLC was carried out with Zorbax SB-C18 column with the column temperature of 25℃. The injection volume was 20 μL. The mobile phase was 0.1% acetic acid water solutiom-acetonitrile (65:35) with the flow rate of 1 ml·min-1. The detector was UVD with the detection wave of 220 nm. Acetonitrile was used as solvent for omarigliptin. RESULTS Isopropyl benzenesulfonate could be separated completely with good linear relationship in 4-60 μg·mL-1. The average recovery of isopropyl benzenesulfonate was 98.56%(n=9, RSD=3.78%). CONCLUSION This method is simple, reproducible and accurate for determination of genotoxic impurities in omarigliptin bulk drug. |
| Key words: omarigliptin bulk drug genotoxic impurities isopropyl benzenesulfonate HPLC |
