Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Kingdom of Saudi Arabia.
Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Kingdom of Saudi Arabia; Department of Biotechnology and Food Science, Faculty of Applied Sciences, Durban University of Technology, Durban 4000, South Africa.
Spectrochim Acta A Mol Biomol Spectrosc. 2022 Oct 5;278:121303. doi: 10.1016/j.saa.2022.121303. Epub 2022 Apr 28.
Environmental sustainable analytical methods were developed by mathematical modification of UV absorption spectra for quality control study of multicomponent formulations consisting of remogliflozin (REM) and teneligliptin (TEN), with good sensitivity and selectivity. Then analytes were quantified by measuring the peak amplitude of the first derivative spectra at zero crossing points at 230.2 nm and 213.8 nm for REG and TEN in the first derivative method. The second method involves the formation of ratio spectra and taking the absorption difference at two selected wavelengths of peak and trough of a spectrum. In the ratio first derivative method peak amplitudes were measured at 235.2 nm and 259.1 nm for simultaneous quantification of REM and TEN respectively. The fourth method was based on the measurement of the peak amplitude of zero-order spectra of analytes generated from the mixture spectrum by subtraction of a constant from the ratio spectrum followed by multiplication with divisor spectrum, Further, the proposed methods were validated systematically to confirm the linearity, precession, accuracy, sensitivity, and selectivity. Finally, validated UV spectroscopic methods were applied for simultaneous quantification of REM and TEN from formulation, and laboratory mixed solutions and statistically compared with the reported HPLC method. Further, recently developed AGREE, Hexagonal greenness and white analytical chemistry, a whiteness evaluation tools were applied to the proposed UV spectroscopic methods and found to be safer analytical methods, compared to the reported expensive, time-consuming and toxic HPLC method. Hence, proposed UV spectroscopic methods could be used for routine quality control of formulations containing REM and TEN.
建立了环境可持续的分析方法,通过对包含瑞格列净(REG)和替格列汀(TEN)的多组分制剂的紫外吸收光谱进行数学修饰,实现了对其的质量控制研究,该方法具有良好的灵敏度和选择性。然后,通过在一阶导数法中测量零交叉点处的第一衍生物光谱的峰振幅,在 230.2nm 和 213.8nm 处分别对 REG 和 TEN 进行定量分析。第二种方法涉及比值光谱的形成,并在光谱的峰和谷的两个选定波长处测量吸收差。在比值一阶导数法中,分别在 235.2nm 和 259.1nm 处测量峰振幅,以同时定量测定 REM 和 TEN。第四种方法基于从混合物光谱中减去常数后,通过减去常数后的比值光谱测量分析物的零阶光谱的峰振幅,然后用除数光谱相乘,进一步,对所提出的方法进行了系统的验证,以确认线性、精度、准确性、灵敏度和选择性。最后,将验证后的紫外光谱法应用于制剂、实验室混合溶液中 REM 和 TEN 的同时定量分析,并与报道的 HPLC 法进行了统计学比较。此外,最近开发的 AGREE、Hexagonal greenness 和 white 分析化学,一种白度评价工具,被应用于所提出的紫外光谱法,与昂贵、耗时和有毒的 HPLC 法相比,发现这些方法更安全。因此,所提出的紫外光谱法可用于含有 REG 和 TEN 的制剂的常规质量控制。