Drug analysis needs to be cost effective without compromising on accuracy. This is an important principle for both routine quality control and the identification of potentially harmful counterfeit medicines. Near-infrared spectroscopy, or NIRS for short, is a useful part of the pharmaceutical analysis toolbox – and a winning choice thanks to the minimal time and labour resources it consumes, as well as the fully automated online analyses it offers. Not only that, but it also takes simultaneous analysis of multiple substances in its stride. This report illustrates two examples of what it can do.
Efficiency thanks to QbD and PAT
Quality by Design (QbD) and process analytical technology (PAT) are two concepts that have become watchwords for the U.S. Food and Drug Administration (FDA). These approaches aim to increase efficiency in the development and production of drugs. In QbD’s case, trial-and-error processes are replaced with a design which, from the outset, is optimally tuned to the ways in which the drug will be used further down the line – in other words, it is adapted to suit the patient population, the manner in which it will be administered, and so on. The hope is that this will result in production that delivers the desired results from the very start.
Without PAT, however, the QbD approach could not survive. Process analysis is used to monitor production in real time. Thus, it allows alterations to be made during the process itself in order to achieve the intended quality. Not only that, but it also helps to improve understanding of the product and process.
Five-in-one
Metrohm NIRS is a textbook example of process analytical technology, with numerous publications describing how it is implemented in pharmaceutical quality control processes – before, during, and after production. The peaks and troughs found in NIR spectra conceal a multitude of chemical and physical information, and chemometric methods are the key to sifting through and decrypting this.
One example of the extraordinary benefits that this technology brings is simultaneous determination of the five active pharmaceutical ingredients (APIs) used in tablets designed to relieve flu symptoms: paracetamol, ascorbic acid, dextromethorphan hydrobromide, caffeine, and chlorphenamine maleate1. This method is validated in accordance with the directives of the ICH (International Conference on Harmonisation), the EMA (European Medicines Agency), and the PASG (Pharmaceutical Analytical Sciences Group). As a result, it can serve as an approved alternative to the more complex reference method, which requires separate determinations using HPLC and titration.
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