An easy and robust method for Batch characterisation of polysorbates now available for pharmaceutical applications

Pharmaceutical manufacturing operations involving polysorbates just got easier and more precise, thanks to a new analysis method developed by ESA Biosciences, a leader in quality electrochemical (EC) and speciality-detection systems for HPLC. The universal-detection method uses reverse-phase HPLC with the award-winning Corona^®CAD^® (Charged Aerosol Detection) detector for sensitive and robust analysis of polysorbates. It is ideal for both speciation of the various individual components of a non-ionic mixture, and for batch-to-batch comparisons, to measure variations in polysorbate composition from various sources or lots of material.

Pharmaceutical manufacturers use polysorbate-based non-ionic surfactants routinely to solubilise and stabilise a variety of drugs, and to prevent aggregation of expressed proteins in fermentation broth. In addition, these molecules are useful for cleaning manufacturing apparatus in pharmaceutical production. Subsequent measurement of residual surfactants is very important in developing methods for cleaning validations in many organisations.

Until now, determination of these non-ionic surfactants has been complicated - each is composed of a mixture of isomers and congeners. Existing methods have a variety of problems: LC-MS typically requires expert users and is not well-suited to the challenging environment of the manufacturing floor; potentiometry lacks sensitivity; while HPLC-UV and HPLC-ELSD suffer from a lack of both sensitivity and dynamic range.

ESA has outlined the Corona CAD method in a white paper, Characterising Lot-to-Lot Differences in Polysorbate Samples with Universal HPLC Detection. The authors present a simple isocratic method for routinely separating and measuring the individual components of polysorbate mixtures. Six different batches of polysorbates were examined, with results revealing significant differences in the composition and levels of individual components in the polysorbate samples. Download this, and other, Corona CAD white papers from the article link.

The Corona CAD system offers many advantages over ELSD and other approaches, including low nanogram sensitivity, a dynamic range exceeding four orders of magnitude (essential for looking at low levels of degradants in the presence of parent drug), and good precision response factors that are independent of structure and no/low analyte level response 'drop-off'. Corona CAD is a robust, reliable, plug-and-play device, which requires no calibration or optimisation&en;so even those with minimal training can run it. Corona CAD has been adopted widely by many leading pharmaceutical companies worldwide because it solves analytical challenges that no other technology can. The ideal complement to UV detection, Corona CAD delivers orders-of-magnitude advantages in sensitivity, dynamic range, consistency, reproducibility, and ease of use, providing universal high-performance liquid chromatography (HPLC) detection of virtually any non-volatile or semi-volatile compound, including proteins, lipids, carbohydrates, and small molecules.