"The credit for this novel ion-analysis method actually goes to one of our long-standing Corona CAD users - a scientist in the analytical research and development department of one of the world's leading pharmaceutical companies," said Dr Jasmine Gruia-Gray, ESA's vice president of life sciences marketing. "After successfully developing, validating, and transferring a number of other Corona CAD methods to facilities around the globe, he decided to turn his attention to a difficult analysis challenge, ion measurements. The separation and quantitation of counterions (cations or anions associated with the drug) in the pharmaceutical industry is an important determination. During drug development, the selection of the correct salt form early in the development process can prevent repeating toxicology, biological, and stability studies down the road. In addition, during pharmaceutical manufacturing, ion measurements of the active pharmaceutical ingredient are a routine part of the QA/QC process to ensure the safety, identity, strength, purity, and quality of the material."
The traditional method for ion measurement uses dedicated, single-purpose ion chromatography (IC) systems, which must be run by highly skilled operators with specialised reagents under tightly controlled conditions. In IC, conductivity detection is used with a suppressor to reduce the background signal. Separate equipment (exchange columns and suppressors) is required to measure cations and anions. This can be cumbersome and time-consuming. The cost of analysis is high: the use of resources - both human and instrument - is inefficient, and the quality of the data generated can lack the necessary accuracy and precision required.
Dr. Gruia-Gray continued, "Our Corona CAD user came up with an elegant solution combining the CAD's universal detection with hydrophilic interaction chromatography (HILIC). The beauty of the CAD method is that it is applicable to both the pharmaceutical development laboratory and to the QA/QC process. And easy method validation and transfer is a hallmark of the Corona CAD. The Corona CAD-based method allows simultaneous analysis of anions and cations and exceeds the performance of IC with regard to measurement accuracy and reproducibility. The HILIC chromatography separates both anions and cations from complex samples for easy and reliable detection by the Corona CAD.
"We confirmed the ion-analysis method in our own ESA application laboratories, and have fine-tuned it for use in the pharmaceutical, food and beverage, and fine chemical industries. The Corona CAD method has attracted significant attention by scientists who have been using IC methods reluctantly for lack of an alternative: the Corona CAD method enables them to perform ion analysis quicker, more efficiently, more cost effectively, and with overall better results."
Equally suited to the methods-development laboratory and the factory floor, ESA's Corona CAD system reliably measures compounds, independent of molecular structure, to low-nanogram levels. Charged Aerosol Detection [CAD] is a robust HPLC detection technology that delivers advanced capabilities to every HPLC-user lab. Besides excellent sensitivity, the Corona CAD shows consistent inter-analyte response independent of chemical structure, enabling quantitation across a range that exceeds four orders of magnitude. This breakthrough detector can effectively analyse a wide diversity of chemical structures and important classes of molecules - from small organic molecules, proteins and peptides, to ions, carbohydrates, lipids, and polymers. The Corona CAD makes methods development, validation, and transfer fast and easy for applications in the pharmaceutical, chemical, polymer, food and beverage and oil/petrochemical industries.