Abstract
Stress factors caused by inadequate storage can induce the unwanted degradation of active compounds in pharmaceutical formulations. Resonance Raman spectroscopy is presented as an analytical tool for rapid monitoring of small concentration changes of tetracycline and the metabolite 4˗epianhydrotetracycline. These degradation processes were experimentally induced by changes in temperature, humidity, and irradiation with visible light over a time period of up to 23 days. The excitation wavelength λexc = 413 nm was proven to provide short acquisition times for the simultaneous Raman spectroscopic detection of the degradation of tetracycline and production of its impurity in small sample volumes. Small concentration changes could be detected (down to 1.4% for tetracycline and 0.3% for 4-epianhydrotetracycline), which shows the potential of resonance Raman spectroscopy for analyzing the decomposition of pharmaceutical products.
Highlights
Antibiotics are used for the treatment of a broad range of infections caused by gram-positive and gram-negative bacteria [1]
Raman spectroscopy has been developed for the analysis of pharmaceutical samples [28,29,30,31,32,33,34,35,36,37,38,39]
This work investigates the stability of the active pharmaceutical ingredient (API) during stress treatments which are typical for inadequate storage, by monitoring the degradation of TC and its metabolite EATC in a pharmaceutical formulation
Summary
Antibiotics are used for the treatment of a broad range of infections caused by gram-positive and gram-negative bacteria [1]. Raman spectroscopy has been developed for the analysis of pharmaceutical samples [28,29,30,31,32,33,34,35,36,37,38,39] This technique [40] provides several advantages as a non-invasive [41], label-free [42,43,44,45,46,47,48], fast and sensitive [49,50,51,52,53] method that can be applied on-site [54,55,56,57,58,59,60] and for the simultaneous analysis of various metabolites. This work investigates the stability of the API during stress treatments which are typical for inadequate storage, by monitoring the degradation of TC and its metabolite EATC in a pharmaceutical formulation
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