Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Quantification and Validation of Mesylate Ion in Dabigatran Etexilate Mesylate and Simultaneous Separation of Some Pharmaceutical Counterions using HPLC-HILIC Coupled with Corona Charged Aerosol Detector

Quantification and Validation of Mesylate Ion in Dabigatran Etexilate Mesylate and Simultaneous... Abstract Several counterions are commonly observed to be associated with drugs to improve their physicochemical properties. Counterions belonging to both inorganic and organic nature, like, I−, NO −, Br−, Cl−, K+, Na+, Li+, PO3− 4, SO2− 4, Zn2+, Mg2+, Ca2+, glutarate, succinate, mesylate, fumarate, citrate, oxalate and tartrate were chosen for the study. HPLC equipped with ZIC®-HILIC column with gradient elution and Corona – CAD was used to separate and detect various counterions in APIs. We have also demonstrated the application of the developed method by separating the counterions in dabigatran etexilate mesylate and sodium potassium tartrate. Further, the method was also applied to quantify the mesylate in dabigatran etexilate mesylate by CAD. This has been validated by determining system suitability, specificity, linearity, and accuracy. The linearity (r2>0.99) of the method was observed over the range from LOQ to 200%. The concentrations were 100 µg mL−1 for LOQ and 33 µg mL−1 for LOD. RSD of LOQ was ≤ 0.20 for standard methane sulphonic acid. The results of quantification of counterion mesylate by CAD were comparable with that of potentiometric titration. The method, thus can be used for determination and identification of anions and cations with API, carbohydrates and peptides. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Quantification and Validation of Mesylate Ion in Dabigatran Etexilate Mesylate and Simultaneous Separation of Some Pharmaceutical Counterions using HPLC-HILIC Coupled with Corona Charged Aerosol Detector

Download PDF

Quantification and Validation of Mesylate Ion in Dabigatran Etexilate Mesylate and Simultaneous Separation of Some Pharmaceutical Counterions using HPLC-HILIC Coupled with Corona Charged Aerosol Detector

Abstract

Abstract Several counterions are commonly observed to be associated with drugs to improve their physicochemical properties. Counterions belonging to both inorganic and organic nature, like, I−, NO −, Br−, Cl−, K+, Na+, Li+, PO3− 4, SO2− 4, Zn2+, Mg2+, Ca2+, glutarate, succinate, mesylate, fumarate, citrate, oxalate and tartrate were chosen for the study. HPLC equipped with ZIC®-HILIC column with gradient elution and Corona – CAD was used to...
Loading next page...
 
/lp/taylor-francis/quantification-and-validation-of-mesylate-ion-in-dabigatran-etexilate-sSU96U8ypz
Publisher
Taylor & Francis
Copyright
© 2022 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2021.1987319
Publisher site
See Article on Publisher Site

Abstract

Abstract Several counterions are commonly observed to be associated with drugs to improve their physicochemical properties. Counterions belonging to both inorganic and organic nature, like, I−, NO −, Br−, Cl−, K+, Na+, Li+, PO3− 4, SO2− 4, Zn2+, Mg2+, Ca2+, glutarate, succinate, mesylate, fumarate, citrate, oxalate and tartrate were chosen for the study. HPLC equipped with ZIC®-HILIC column with gradient elution and Corona – CAD was used to separate and detect various counterions in APIs. We have also demonstrated the application of the developed method by separating the counterions in dabigatran etexilate mesylate and sodium potassium tartrate. Further, the method was also applied to quantify the mesylate in dabigatran etexilate mesylate by CAD. This has been validated by determining system suitability, specificity, linearity, and accuracy. The linearity (r2>0.99) of the method was observed over the range from LOQ to 200%. The concentrations were 100 µg mL−1 for LOQ and 33 µg mL−1 for LOD. RSD of LOQ was ≤ 0.20 for standard methane sulphonic acid. The results of quantification of counterion mesylate by CAD were comparable with that of potentiometric titration. The method, thus can be used for determination and identification of anions and cations with API, carbohydrates and peptides.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Mar 4, 2022

Keywords: Corona charged aerosol detection; Dabigatran Etexilate Mesylate; High-performance hydrophilic interaction liquid chromatography; Pharmaceutical counterions; methane sulphonic acid Potentiometric titration

References

  • Drug Solubility: Importance and Enhancement Techniques
  • Determining a Solubility Product Constant by Potentiometric Titration to Increase Students’Conceptual Understanding of Potentiometry and Titrations
  • Determination of Amoxicillin by Flow Injection Analysis using UV-Detection, Potentiometry, and Conductometry in Pharmaceutical Preparations
  • Combined HILIC-ELSD/ESI-MSn enables the separation, identification and quantification of sugar beet pectin derived oligomers
  • Preparation and chromatographic performance of polymer-based anion exchangers for ion chromatography: A review
  • Separation, preconcentration and inductively coupled plasma-mass spectrometric (ICP-MS) determination of thorium (IV), titanium(IV), iron(III), lead (II) and chromium(III) on 2-nitroso-1-naphthol impregnated MCI GEL CHP20P resin
  • Comparison of two evaporative universal detectors for the determination of sugars in food samples by liquid chromatography
  • Recent applications of the Charged Aerosol Detector for liquid chromatography in drug quality control
  • Aerosol-based detectors for liquid chromatography
  • Direct determination of amino acids by hydrophilic interaction liquid chromatography with charged aerosol detection
  • Development and validation of a stability-indicating HPLC method for topiramate using a mixed-mode column and charged aerosol detector
  • Lipid analysis via HPLC with a charged aerosol detector
  • HILIC behavior of a reversed-phase/ cation-exchange/ anion-exchange trimode column
  • A Bidentate Amino Stationary Phase for Hydrophilic Interaction Chromatography
  • Understanding and manipulating the separation in hydrophilic interaction liquid chromatography
  • High-Performance Liquid Chromatography Determination of Free Sugars and Mannitol in Mushrooms Using Corona Charged Aerosol Detection
  • Analysis of Aqueous Alkanolamines Using Hydrophilic Interaction Liquid Chromatography and Mass Spectrometry
  • Hydrophilic interaction liquid chromatography (HILIC)-a powerful separation technique
  • Retention Behavior of Inorganic Anions in Hydrophilic Interaction Chromatography
  • Development and validation of a hydrophilic interaction chromatography method coupled with a charged aerosol detector for quantitative analysis of nonchromophoric α-hydroxyamines, organic impurities of metoprolol
  • Determination of inorganic pharmaceutical counterions using hydrophilic interaction chromatography coupled with a Corona® CAD detector
  • Simultaneous Determination of Positive and Negative Counterions Using a Hydrophilic Interaction Chromatography Method
  • Validation of an HPLC Method for the Determination of Sodium in LY293111 Sodium, a Novel LTB4 Receptor Antagonist, Using Evaporative Light Scattering Detection
  • Simultaneous determination of positive and negative pharmaceutical counterions using mixed-mode chromatography coupled with charged aerosol detector
  • Hydrolytic Degradation Study of Dabigatran Etexilate Mesylate: Isolation and Structural Elucidation of New Degradants
  • Charged aerosol detector response modeling for fatty acids based on experimental settings and molecular features: a machine learning approach