| 引用本文: | 李丹,王淑君,姚慧敏,姜玮伦,于海伟,徐莹.离子色谱法测定氟达拉滨中三氟甲磺酸酯类遗传毒性杂质[J].中国现代应用药学,2019,36(20):2557-2560. |
| LI Dan,WANG Shujun,YAO Huimin,JIANG Weilun,YU Haiwei,XU Ying.Determination of Genetic Toxic Impurities of Trifluoromethanesulfonate in Fludarabine by Ion Chromatography[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(20):2557-2560. |
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| 离子色谱法测定氟达拉滨中三氟甲磺酸酯类遗传毒性杂质 |
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李丹1,2, 王淑君1, 姚慧敏3, 姜玮伦3, 于海伟2, 徐莹2
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1.沈阳药科大学药学院, 沈阳 110016;2.沈阳鑫泰格尔医药科技开发有限公司, 沈阳 110016;3.通化师范学院制药与食品科学学院, 吉林 通化 134002
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| 摘要: |
| 目的 采用离子色谱法对氟达拉滨中的三氟甲磺酸酯类遗传毒性杂质进行测定。方法 采用十八烷基硅烷键合硅胶为填充剂，洗脱液：[0.15 mmol·L-1四丁基氢氧化铵-0.090 mmol·L-1苹果酸（pH 6.5）]-乙腈（70：30），流速为1.0 mL·min-1，柱温为35℃，检测方式为直接电导检测。结果 有效测定了氟达拉滨中的三氟甲磺酸酯类遗传毒性杂质，检测限为2.5 μg·mL-1，定量限为7.4 μg·mL-1，线性范围为1.917~22.344 mg·L-1，r=0.997 4，方法耐用性好。结论 本法可有效检测氟达拉滨中的三氟甲磺酸酯类遗传毒性杂质，方法灵敏度高，准确度高，耐用性好。 |
| 关键词: 离子色谱法 三氟甲磺酸酯类 遗传毒性杂质 氟达拉滨 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.20.014 |
| 分类号:R917.101 |
| 基金项目: |
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| Determination of Genetic Toxic Impurities of Trifluoromethanesulfonate in Fludarabine by Ion Chromatography |
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LI Dan1,2, WANG Shujun1, YAO Huimin3, JIANG Weilun3, YU Haiwei2, XU Ying2
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1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;2.Shenyang Xintaige Pharmaceutical Technology Development Co., Ltd., Shenyang 110016, China;3.School of Pharmaceutical and Food Sciences, Tonghua Normal University, Tonghua 134002, China
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| Abstract: |
| OBJECTIVE To determine the genotoxic impurities of trifluoromethanesulfonate fludarabine by ion chromatography. METHODS The method was achieved on a C18 column utilizing an eluent of[0.15 mmol·L-1 tetrabutylammonium hydroxide-0.090 mmol·L-1 malic acid (pH 6.5)]-acetonitrile (70:30) at a flow rate of 1.0 mL·min-1 and the column temperature was 35℃, the detection method was direct conductivity detection. RESULTS This method could effectively determine the trifluoromethanesulfonate genotoxic impurities in fludarabine. The detection limit was 2.5 μg·mL-1 and the limit of quantification was 7.4 μg·mL-1, the linear range was 1.917-22.344 mg·L-1, r=0.997 4. The method had good durability. CONCLUSION This method can effectively detect the genotoxic impurities of mesylate analogues. The method has high sensitivity, high accuracy and good durability. |
| Key words: ion chromatography trifluoromethanesulfonate genotoxic impurities fludarabine |
