Corona^® CAD^® Simplifies Analysis of Cations and Anions: New Method is More Efficient, Accurate, Reliable, and Cost-Effective than Traditional Techniques

ESA Biosciences, Inc., a Magellan Biosciences company and leader in novel HPLC systems that improve results for pharmaceutical development and QA/QC, life science, and analytical-chemistry customers worldwide, now has a simple and reliable HPLC method for simultaneous measurement of cations and anions, using its award-winning Corona CAD universal detector. Since positive ions (cations) and negative ions (anions) are key components of everything from pharmaceuticals to food and beverages to fine chemicals, analysis of these atoms and molecules is a critical step in product development and QA/QC. The new Corona CAD method improves results for users: it is more efficient than traditional techniques, since it measures anions and cations in a single run, and it is also more accurate, reliable, and cost-effective.

“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 Jasmine Gruia-Gray, PhD, 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 specialized 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 broad uses across 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.”