Revolutionising Raman with the transmission technique
Posted: 3 July 2015 |
All regulatory agencies require that manufacturers accurately determine the amount of drug in a medicinal product so that the product can be deemed fit for patients. This forms part of batch release testing performed by Quality Control (QC) laboratories. The drug assay and/or content uniformity of the dosage units is typically performed by a wet chemistry technique that has not significantly changed in the industry for four decades.
High performance liquid chromatography (HPLC) is widely used by laboratories for that purpose, and automated sample preparation systems are available. But there are drawbacks to these methods. This article explores how Transmission Raman now has the potential to revolutionise the release testing of pharmaceutical product in a QC laboratory.
HPLC is a slow and labour-intensive technique as analyses require the preparation of samples and standards, as well as instrument run times measured in hours. In addition, the sample preparation is typically conducted by bench chemists and human error can result in inaccurate results, leading to lengthy investigations and delays in product release. Meanwhile, for products that are infrequently tested, the cost of using automated sample preparation systems can be prohibitive. Ultra performance liquid chromatography (UPLC) is another method used – it does reduce the duration of the runs on the instrument, but the amount of time spent by laboratory personnel on sample preparation remains unchanged.
Actavis UK Ltd undertook a project to modernise how samples were tested in the QC laboratory, making significant improvements to the supply chain and speeding up the process of product supply to the market. After reviewing the technologies that can non-destructively test solid oral medicinal products, Transmission Raman spectroscopy was identified as the most chemically specific alternative that avoids sub sampling issues from the tablets or capsules. The technique eliminates sample and standard preparation time, with routine sample analysis in just minutes, and as the added benefit of eliminating environmental waste. Training to perform the routine analysis is extremely quick compared to the conventional chromatography techniques…