Retention Processes in Ion‐Exclusion Chromatography: A New Perspective

Novič, Milko; Haddad, Paul R.

doi:10.1002/9781118147009.ch2

Cited by 1 publication

(1 citation statement)

References 31 publications

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“…Comprehensive information on the many methods accessible can be obtained by chromatographic methods such as HPLC [10], HPLC [11][12][13][14], LC MS [15][16][17][18][19], and CAA material [20][21][22][23] by various methods. Ion chromatography (IC) [24][25][26][27][28][29] has recently emerged as a popular analytical tool for determining inorganic cations and organic acids in a variety of matrices. As far as we are aware, no IC experiments have been made to date in order to identify CAA content in TFM.…”

Section: Introductionmentioning

confidence: 99%

Quantitative determination of cyanoacetic acid content in teriflunomide drug substance by ion chromatography using conductivity detector

et al. 2021

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Background The current study focuses on the development and validation of an analytical method for quantifying cyanoacetic acid (CAA) in teriflunomide drug substance using a high-performance ion chromatography (IC) with cation suppressed conductivity detection (TFM). Water was used as the diluent for preparing the sample solution, which was injected into a standard chromatographic device with 250 mm, 4.0 mm ID, and 5.0 μm particle size Metrosep A Supp 5 Ion exchange column and a suppressed conductivity detector. At a flow rate of 0.6 mL min−1 and a temperature of 40 °C, the mobile phase was delivered in an isocratic mode. Results CAA and TFM had retention times of 12.78 and 15.82 min, respectively. CAA has a limit of detection (LOD) of 33 μg/g and a limit of quantification (LOQ) of 101 μg/g, respectively. For LOD and LOQ accuracy, the percentage RSD of CAA is 1.7 and 1.2, respectively. The average CAA recovery percentage was found to be between 98.6 and 100.1%. With a value of 0.9998, the calibration curve yielded an excellent linear correlation coefficient for CAA. According to the ICH guidelines, all verification parameters are within the range, indicating that the system is stable. Conclusion The elution time and run time in the currently developed ion chromatography analytical method have been reduced, demonstrating that the method is cost-effective and generally accepted, as well as simple and functional, and can be used in routine quality control tests in the industry.

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