离子色谱法用于卡铂注射液中依地酸二钠含量测定的研究
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- 英文论文题名：Research on IC Determination of EDTA in Carboplatin Injection
- 论文作者：高旋 ; 金薇 ; 杨永健
- 英文论文作者：GAO Xuan ; JIN Wei ; YANG Yong-jian ; Shanghai Institute for Food and Drug Control
- 年：2016
- 作者机构：上海市食品药品检验所;
- 论文关键词：离子色谱 ; 依地酸二钠 ; 卡铂注射液
- 英文论文关键词：ion chromatography ; EDTA-2Na ; carboplatin injection
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R927.2;O657.75
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：4
- 文件大小：315k
- 原文格式：O
- 会议级别：全国
摘要
目的建立含金属铂药物卡铂注射液中依地酸二钠含量的离子色谱测定方法,并与经典柱前衍生高效液相色谱法测定结果进行了比较。方法采用戴安IonPacCS-12A阳离子交换色谱柱(4.0mm×250mm),IonPacCS-12Aguard保护柱(4.0mm×50mm),淋洗液为10mmol/L甲烷磺酸水溶液,流速1.0mL·min~(-1),采用电导检测器,抑制电流为30mA,检测器温度35℃,柱温30℃,进样体积25μL,外标法定量。结果乙二胺四醋酸二钠在0.015~0.040mg·mL~(-1)内呈良好线性关系,相关系数为0.9997(n=5),平均回收率为102.3%(n=9)。结论该方法简便、准确、重现性好,可有效用于卡铂注射液中依地酸二钠的含量测定,结果可用于评价卡铂注射液中添加依地酸二钠的合理性。
OBJECTIVE To develop a method by ion chromatography with suppressed conductivity detection for the determination of EDTA-2Na in Carboplatin injection.METHODS Chromatographic separation was achieved on an IonPac CS 12 A column(4.0mm×250mm) with an IonPac CS 12 A guard column(4.0mm×50mm).The eluent was 10mmol·L~(-1) MSA with flow rate 1.0mL·min~(-1).The CSRS suppressor(4mm) current was 30 mA,and the conductivity detector temperature was set at 35℃ while the column temperature was maintained at 30℃.The injection volume was 25 uL,and the external standard method was adopted.RESULTS A good linear relationship was obtained in the concentration range of 0.015~0.040mg·mL~(-1)and the correlation coefficient was 0.9997(n=5).The average recovery of the EDTA-2Na was 102.3%(n=9).CONCLUSION The proposed method shows high selectivity and good results.It is proved to be rapid and convenient,and it can be employed for the quality control and research of EDTA-2Na in carboplatin injection.
OBJECTIVE To develop a method by ion chromatography with suppressed conductivity detection for the determination of EDTA-2Na in Carboplatin injection.METHODS Chromatographic separation was achieved on an IonPac CS 12 A column(4.0mm×250mm) with an IonPac CS 12 A guard column(4.0mm×50mm).The eluent was 10mmol·L~(-1) MSA with flow rate 1.0mL·min~(-1).The CSRS suppressor(4mm) current was 30 mA,and the conductivity detector temperature was set at 35℃ while the column temperature was maintained at 30℃.The injection volume was 25 uL,and the external standard method was adopted.RESULTS A good linear relationship was obtained in the concentration range of 0.015~0.040mg·mL~(-1)and the correlation coefficient was 0.9997(n=5).The average recovery of the EDTA-2Na was 102.3%(n=9).CONCLUSION The proposed method shows high selectivity and good results.It is proved to be rapid and convenient,and it can be employed for the quality control and research of EDTA-2Na in carboplatin injection.
引文
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[2]YUAN W,ZHAO Q,XU K K.Determination of Disodium Edetate in Omeprazole Sodium for Injection by RP-HPLC[J].Anhui Medical and Pharmaceutical Journal(安徽医药),2010,14(5):537-538.
[3]SUNC X,HANWF,LI J.Detennination of Edetate Disodium in Sodium Chloride Eye Drops by HPLC[J].Food and Drug(食品与药品),2015,17(4):270-272.
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[5]DIAO Y Z,HAN J Y,CHEN X F.HPLC Determination of Disodium Edetate in Pantoprazole Sodium for Injection[J].Chin J Pham Anal(药物分析杂质),2011,31(2):282-284.
[2]YUAN W,ZHAO Q,XU K K.Determination of Disodium Edetate in Omeprazole Sodium for Injection by RP-HPLC[J].Anhui Medical and Pharmaceutical Journal(安徽医药),2010,14(5):537-538.
[3]SUNC X,HANWF,LI J.Detennination of Edetate Disodium in Sodium Chloride Eye Drops by HPLC[J].Food and Drug(食品与药品),2015,17(4):270-272.
[4]NIU X S,YUAN H F,QIAN G Y.Determination of Disodium Edetate in Adrenaline Hydrochloride Injections by HPLC[J].China Pharmacist(中国药师),2013,16(10):1497-1499.
[5]DIAO Y Z,HAN J Y,CHEN X F.HPLC Determination of Disodium Edetate in Pantoprazole Sodium for Injection[J].Chin J Pham Anal(药物分析杂质),2011,31(2):282-284.