Determination of Trifluoroacetic Acid(TFA) Residues in Linagliptin Drugs by Ion Chromatography with Direct Conductance
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Determination of Trifluoroacetic Acid(TFA) Residues in Linagliptin Drugs by Ion Chromatography with Direct Conductance
Vol. 34, Issue 12, Pages: 1425-1429(2015)
作者机构:
迪沙药业集团国家认定企业技术中心质量研究院
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Determination of Trifluoroacetic Acid(TFA) Residues in Linagliptin Drugs by Ion Chromatography with Direct Conductance. [J]. 34(12):1425-1429(2015)
DOI:
Determination of Trifluoroacetic Acid(TFA) Residues in Linagliptin Drugs by Ion Chromatography with Direct Conductance. [J]. 34(12):1425-1429(2015)DOI:
Determination of Trifluoroacetic Acid(TFA) Residues in Linagliptin Drugs by Ion Chromatography with Direct Conductance
An ion chromatographic method was developed for the determination of trifluoroacetic acid(TFA) residues in linagliptin drugs.After dissolved with dichlomethane and extracted with water,the samples were loaded onto the instument.The determination was performed on an Ionpac AS11-HC(4 mm×25 cm) column with an IonpacAG11-HC(4 mm×5 cm) guard column.The eluent was 20 mmol/L potassium hydroxide solution produced on-line with EGⅢ KOH at a flow rate of 12 mL/min.TFA was detected by suppressed conductivity with an ASRS 500-4 mm suppressor at a current of 60 mA.The column temperature was set at 30 ℃ and the injection volume was 25 μL.There was a good resolution between trifluoroacetic acid and other components.The calibration curve showed a good linearity(r=0.999 4) in the range of 0.848-6.46 μg/mL.The limit of detection(LOD) was 0.031 8 μg/mL and the limit of quantitation(LOQ) was 0.106 μg/mL.The method has the advantages of simple operation,high sensitivity and good reproducibility,and could be used for the detection of trifluoroacetic acid(TFA) residues in linagliptin drugs.
关键词
离子色谱-直接电导法三氟乙酸利格列汀
Keywords
ion chromatography with direct conductancetrifluoroacetic acid(TFA)linagliptin