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5PSQ-054 Examination of a new method for analysing identity and concentration of drugs in ready to use preparations: proof of concept of the DrugLog system
  1. B Witter,
  2. C Kock-Hauser,
  3. A Liekweg
  1. University Hospital Cologne, Pharmacy, Cologne, Germany


Background and importance The increasing awareness of drug therapy safety and at the same time immense skills shortages pose new challenges for hospital pharmacies. The number of ready to use preparations has increased, especially in high risk fields such as oncological and paediatric medicine. For immediate quality control, in accordance with the German and European Pharmacopoeia, there is a need for analytical methods which (1) do not require large volumes for testing and (2) are safe and fast in processing with accurate results. Pharmacolog (Upsala, Sweden) promotes the UV/Vis spectrometer DrugLog with these features.

Aim and objectives The aim of examining DrugLog was to test the reliability and precision of the method as well as the process for optimisation during quality control. As part of this, sample extraction without further processing in terms of everyday usability and safety, especially in the analysis of cytostatic drugs, was examined.

Material and methods The drugs norepinephrine, midazolam, atropine and cytarabine were tested during the first step. Standard curves of each drug were created in the system. Samples of ready to use preparations were analysed without further processing with 0.5 mL sample volumes each in micro UV single use cuvettes with a lid. For preparations of cytarabine cuvettes, Luer-Lock closures were used. The content as well as the identity of drugs were determined simultaneous in the instrument. The method of the DrugLog system was compared with the established methods.

Results All tested substances were analysed reliable with the new method. The cytostatic drug cytarabine was analysed without cytotoxic contamination of staff or equipment. Measurement of atropine was possible with the DrugLog system at a minimum concentration of 0.05 mg/mL even with low UV absorption. The total time required for the analyses was reduced by 50–75% compared with the established UV-Vis analysis, depending on the drug analysed.

Conclusion and relevance DrugLog simplified processing, provided maximum work safety when dealing with cytotoxic drugs and provided stable results for the tested drugs. Each drug required a separate calibration. For substances without UV activity or very similar spectra, the methodology has limitations. Future investigations are planned, in particular for application in paediatric settings.

References and/or acknowledgements German and European Pharmacopoeia.

No conflict of interest.

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