离子色谱法测定坎地沙坦酯中乙酸的残留  

Ion chromatography determination of acetic acid residue in candesartan cilexetil

作　　者：樊玉丹 李银峰[2] 姜瑛[3] 陈晓雨[1] 靳朝东[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津药物研究院分析测试中心,天津300193 [3]天津泰普药品科技发展有限公司,天津300193

出　　处：《药物评价研究》2016年第2期242-244,共3页Drug Evaluation Research

摘　　要：目的建立离子色谱法（IC）检测坎地沙坦酯中乙酸的残留量。方法使用IonPac AS11-HC分析柱（250mm×4mm）、IonPacAG11-HC保护柱（50mm×4mm），洗脱液为1mmol／L的KOH、抑制电流为3mA，体积流量为1mL／min，柱温为30℃，进样体积为50μL。结果乙酸在0．0625～5μg／mL线性关系良好（r=0．999）。检测限为0．78ng。平均加样回收率为102．32％，RSD=3．65％。结论此方法可以测定坎地沙坦酯样品中乙酸的残留，方法简单、准确度高。Objective To develop an ion chromatography （IC） method for determining the content of acetic acid in candesartan cilexetil. Methods Analytical column IonPac ASll-HC （250 mm × 4 mm） and guard column IonPac AGll-HC （50 mm × 4 mm） were used, 1 mmol/L of KOH as eluent, 3 mA of curb, and a flow rate of 1.0 mL/min were used with a column temperature of 30 ℃ and 50 iL of injection volume. Results The calibration curve of acetic acid was linear over the range of 0.0625-5 ig/mL （r = 0.999）. The detection limit was 0.78 ig. The average recovery of method was 102.32%, RSD = 3.65%. Conclusion The method of content determination is practicable and of high accuracy. Thus, it can be used for the content determination of acetic acid in candesartan cilexetil.

关 键 词：离子色谱法 坎地沙坦酯 乙酸 残留溶剂 

分 类 号：R917[医药卫生—药物分析学]