Abstract <p>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.</p> Purpose <p>We 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.</p> Methods <p>Meropenem 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).</p> Results <p>Test results indicated a significant decrease in meropenem concentration during infusion. Notably, each test required only 8&#xa0;s. No sample preparation was needed.</p> Conclusion <p>This 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.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Nondestructive and Rapid Dynamic Monitoring of Drug Stability During Infusion via Portable Raman Spectroscopy Analysis Method

  • Yuting Huang,
  • NingNing Wang,
  • Sisi Wang,
  • Haitao Liu

摘要

Abstract

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.

Purpose

We 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.

Methods

Meropenem 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).

Results

Test results indicated a significant decrease in meropenem concentration during infusion. Notably, each test required only 8 s. No sample preparation was needed.

Conclusion

This 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.