Department of Pharmacy, University of Patras, University Campus, GR-26504 Rio Achaias, Greece.
Institute of Chemical Engineering Sciences, Foundation of Research and Technology-Hellas (ICE-HT/FORTH), GR-26504 Platani Achaias, Greece.
Molecules. 2020 Dec 21;25(24):6051. doi: 10.3390/molecules25246051.
FT-IR/ATR analytical technique is one of the most applicable techniques worldwide. It is closely associated with easy-to-use equipment, rapid analysis, and reliable results. This study reports the simultaneous qualitative and quantitative analysis of two active pharmaceutical ingredients (APIs), of a piperacillin and tazobactam formulation using a film formation method. This method requires film formation on the ATR crystal, resulting from solvent evaporation of a small amount of liquid sample. Good contact between the film and the crystal led to the identification of both APIs, although tazobactam was of low content in the formulation mixture. The quantification of the APIs in the commercial mixture was also achieved, using a single calibration line with a correlation coefficient equal to 0.999, not only after film formation but also in the initial dry formulation before reconstitution. The present spectroscopic technique combined with the proposed relatively simple sample treatment outweighs chromatographic protocols already applied, which require specialized staff and are costly, time-consuming, and not environmentally friendly. Taking all the above into consideration, it turns out that such an approach has the potential to be used for off-line quality control procedures in manufacture or, in terms of portable equipment and automated software, anywhere for on-site analysis, even in a hospital workflow.
傅里叶变换衰减全反射/衰减全反射(FT-IR/ATR)分析技术是目前全球应用最广泛的技术之一。它与易于使用的设备、快速分析和可靠的结果密切相关。本研究报告了一种使用成膜方法同时对两种活性药物成分(APIs),即哌拉西林和他唑巴坦制剂进行定性和定量分析的方法。该方法需要在 ATR 晶体上形成薄膜,这是通过少量液体样品的溶剂蒸发实现的。薄膜与晶体之间的良好接触导致了两种 API 的鉴定,尽管他唑巴坦在制剂混合物中的含量较低。通过使用具有等于 0.999 的相关系数的单个校准曲线,还可以实现商业混合物中 API 的定量,不仅在成膜后,而且在重新配制前的初始干制剂中也是如此。本研究提出的将这种光谱技术与相对简单的样品处理相结合的方法优于已经应用的色谱方案,因为后者需要专门的人员,并且成本高、耗时、不环保。综上所述,这种方法有可能用于生产过程中的离线质量控制程序,或者在便携式设备和自动化软件的支持下,在任何地方进行现场分析,甚至在医院的工作流程中也可以进行。