Nondestructive and Rapid Dynamic Monitoring of Drug Stability During Infusion via Portable Raman Spectroscopy Analysis Method
摘要
Drug stability during infusion is often overlooked in clinical practice. This oversight compromises drug safety and efficacy. Conventional analytical methods for drug stability include High Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS). These methods require professional operators and lengthy analysis times.
PurposeWe aimed to establish a rapid and nondestructive process analytical technology (PAT) for infusion stability studies. Thus, we developed a Raman spectroscopy analysis method, which just needs seconds to test every sample.
MethodsMeropenem was selected as a test drug due to its poor stability in water solution. An I-Raman portable Raman spectrometer in combination with an auxiliary detection device were used. Meropenem was dissolved and diluted with Normal Saline (NS) and 5% Dextrose in Water (D5W).
ResultsTest results indicated a significant decrease in meropenem concentration during infusion. Notably, each test required only 8 s. No sample preparation was needed.
ConclusionThis method enables rapid, non-sampling testing of clinical infusion samples. The portable Raman spectroscopy analysis method has promising potential in fast and point-of-care clinical drug testing.