Eksi-Kocak Haslet, Ilbasmis Tamer Sibel, Yilmaz Sebnem, Eryilmaz Merve, Boyaci Ismail Hakkı, Tamer Ugur
Department of Biomedical Engineering, Faculty of Engineering, Istanbul Aydin University, Istanbul 34295, Turkey.
Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler, Ankara 06330, Turkey.
Asian J Pharm Sci. 2018 Mar;13(2):155-162. doi: 10.1016/j.ajps.2017.07.010. Epub 2017 Oct 20.
In this study, we proposed a rapid and sensitive method for quantification and spatial distribution of salicylic acid in film tablets using FT-Raman spectroscopy with multivariate curve resolution (MCR). For this purpose, the constituents of film tablets were identified by using FT-Raman spectroscopy, and then eight different concentrations of salicylic acid tablets were visualized by Raman mapping. MCR was applied to mapping data to expose the active pharmaceutical ingredients in the presence of other excipients by monitoring distribution maps and combination of FT-Raman mapping with MCR enabled the determination of lower salicylic acid concentrations. In addition, the distribution of major excipient, lactose, was examined in the tablet form. A calibration curve was obtained by plotting the intensity of the Raman signal at 1635 cm versus the concentration of salicylic acid and the correlation was found to be linear within the range of 0.5%-3.9% with a correlation coefficient of 0.99. The limit of detection for the technique was determined 0.35%. The ability of the technique to quantify salicylic acid in tablet test samples was also investigated.
在本研究中，我们提出了一种利用傅里叶变换拉曼光谱结合多元曲线分辨（MCR）技术对薄膜包衣片中水杨酸进行定量和空间分布分析的快速灵敏方法。为此，首先利用傅里叶变换拉曼光谱对薄膜包衣片的成分进行鉴定，然后通过拉曼映射对八种不同浓度的水杨酸片进行可视化分析。将MCR应用于映射数据，通过监测分布图来揭示在其他辅料存在下的活性药物成分，傅里叶变换拉曼映射与MCR相结合能够测定更低浓度的水杨酸。此外，还对主要辅料乳糖在片剂中的分布进行了研究。通过绘制1635 cm处拉曼信号强度与水杨酸浓度的关系曲线得到校准曲线，发现在0.5%-3.9%的范围内相关性呈线性，相关系数为0.99。该技术的检测限为0.35%。同时还研究了该技术对片剂测试样品中水杨酸进行定量的能力。
