Clinical Pharmacy Department, HU Necker-Enfants Malades (AP-HP), Paris, France.
Clinical Pharmacy Department, HU Necker-Enfants Malades (AP-HP), Paris, France.
Int J Pharm. 2014 Aug 15;470(1-2):70-6. doi: 10.1016/j.ijpharm.2014.04.064. Epub 2014 May 2.
The purpose of the study was to perform a comparative analysis of the technical performance, respective costs and environmental effect of two invasive analytical methods (HPLC and UV/visible-FTIR) as compared to a new non-invasive analytical technique (Raman spectroscopy). Three pharmacotherapeutic models were used to compare the analytical performances of the three analytical techniques. Statistical inter-method correlation analysis was performed using non-parametric correlation rank tests. The study's economic component combined calculations relative to the depreciation of the equipment and the estimated cost of an AQC unit of work. In any case, analytical validation parameters of the three techniques were satisfactory, and strong correlations between the two spectroscopic techniques vs. HPLC were found. In addition, Raman spectroscopy was found to be superior as compared to the other techniques for numerous key criteria including a complete safety for operators and their occupational environment, a non-invasive procedure, no need for consumables, and a low operating cost. Finally, Raman spectroscopy appears superior for technical, economic and environmental objectives, as compared with the other invasive analytical methods.
本研究旨在对两种侵入性分析方法(HPLC 和 UV/可见-FTIR)与一种新的非侵入性分析技术(拉曼光谱)的技术性能、各自的成本和环境影响进行比较分析。使用三种药物治疗模型来比较三种分析技术的分析性能。使用非参数相关等级检验对统计方法间的相关性进行分析。研究的经济部分结合了与设备折旧和估计 AQC 工作单元成本相关的计算。在任何情况下,三种技术的分析验证参数均令人满意,并且发现两种光谱技术与 HPLC 之间具有很强的相关性。此外,与其他技术相比,拉曼光谱在许多关键标准方面具有优势,包括操作人员及其职业环境的完全安全、非侵入性程序、无需消耗品以及低运营成本。最后,与其他侵入性分析方法相比,拉曼光谱在技术、经济和环境目标方面具有优势。