First Specific Analytical Method for Quantification of Halide Ions by UHPLC-MS Using Reverse Phase Chromatography...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Optimizing trace detection and stoichiometry determination of pharmaceutical salts is crucial during drug development.
• Current halide ion detection often relies on ion chromatography (IC), known for specificity and sensitivity.
• Mass spectrometry (MS) offers superior sensitivity and specificity for trace detection and stoichiometric calculations.

Purpose of the Study:

• To develop and validate a novel liquid chromatography-mass spectrometry (LC-MS) method for effective halogen separation and quantification.
• To address the lack of suitable reverse-phase LC-MS methods for accurate halogen analysis in pharmaceutical compounds.
• To enable precise stoichiometric investigations of pharmaceutical salts and halide residues.

Main Methods:

• Development of a rapid and efficient method using a C18 reverse-phase chromatographic system.
• Application of liquid chromatography coupled with mass spectrometry (LC-MS) for sensitive detection and quantification.
• Method validation in compliance with International Council for Harmonisation (ICH) standards.

Main Results:

• Achieved optimal separation of three key halogens using the C18 reverse-phase LC-MS method.
• Demonstrated the method's capability for precise quantification of analytes via mass spectrometry.
• Successfully applied the method to investigate the stoichiometry of pharmaceutical salts.

Conclusions:

• The developed C18 reverse-phase LC-MS method provides an effective solution for halogen separation and quantification in pharmaceuticals.
• This technique enhances accuracy in stoichiometric determination, crucial for pharmaceutical research and development.
• The method supports compliance with regulatory standards for pharmaceutical analysis.