| 马利华,叶海英,杜柳辉,张玫,杨化新.HPLC法测定利奈唑胺中硝基苯类潜在遗传毒性杂质B的含量[J].中国药品标准,2018,19(1):44-48 |
| HPLC法测定利奈唑胺中硝基苯类潜在遗传毒性杂质B的含量 |
| Determination of Potential Genotoxic Impurity B (Nitrobenzene Compounds) in Linezolid by HPLC |
| 投稿时间：2017-10-20 修订日期：2018-02-08 |
| DOI： |
| 中文关键词: 利奈唑胺 硝基苯类 遗传毒性杂质 HPLC法 |
| 英文关键词: Linezolid Nitrobenzene Compounds Genotoxic Impurities HPLC |
| 基金项目: |
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| 摘要点击次数: 582 |
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| 中文摘要: |
| 目的：建立高效液相色谱法测定利奈唑胺中硝基苯类潜在遗传毒性杂质B的含量。方法：以YMC ODS-AM C18(150mm × 4.6mm,5μm)为色谱柱,以0.1%三氟乙酸水溶液-0.1%三氟乙酸乙腈溶液(62:38)为流动相,流速为1.0 mL.min-1,检测波长为368nm,柱温为30℃。结果：杂质B在15~60ng/mL范围内,线性关系良好(R=0.9979)；精密度和溶液稳定性均符合要求；高、中、低3种浓度的平均回收率分别为97.9%、98.2%和97.5%。结论：本方法专属性好,灵敏度高,精密度、准确度好,可用于利奈唑胺原料中硝基苯类潜在遗传毒性杂质的测定。 |
| 英文摘要: |
| OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for the determination of potential genotoxic impurity B (nitrobenzene compounds) in Linezolid. METHODS The analytical column was YMC ODS-AM C18(150mm × 4.6mm, 5μm), the mobile phase was 0.1%TFA- 0.1%TFA/ACN(62:38), the flow rate was 1.0 mL.min-1. The detection wavelength was 368nm, and the column temperature was 30℃. RESULTS The linear range of calibration curve was 15~60 ng.mL-1(R=0.9979). The average recoveries of three concentrations were 97.9%, 98.2%, 97.5%, respectively. CONCLUSION The method is specificity, sensitive, accurate, precision, and can be used for quality control of potential genotoxic impurity B. |
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