Eco-friendly resolution of spectrally overlapping signals of a combined triple-action over-the-counter pharmaceutical formulation for symptomatic management of COVID-19 pandemic: application to content uniformity testing

Abstract

Currently, all researchers are concentrating their efforts on countering the COVID-19 pandemic. The majority of patients are managed at home, according to recent statistics. An OTC triple action combination comprising paracetamol (PAR), aspirin (ASP), and diphenhydramine (DIPH) is commonly given for pain relief, fever control, and as a night-time sleep aid. This combination is currently recommended for COVID-19 patients as part of symptomatic treatment and management. In this work, three smart, simple, accurate, eco-friendly, and cost-effective spectrophotometric methods are developed for simultaneous determination of PAR, ASP, and DIPH in their combined over-the-counter caplet dosage form without any prior separation steps. The first method is the first derivative spectrophotometry (D1) which determined PAR at 259.7 nm. The second one is the dual-wavelength in ratio spectra (DWRS) for determination of ASP at 214.1 and 220.1 nm after using 10.0 μg/mL of PAR as a divisor, where PAR was a constant, and the wavelengths difference equal to zero for DIPH. The third method is the double divisor-ratio difference spectrophotometric one (DD-RD) which was based on using the sum of 15.0 µg/mL of each of PAR and ASP as a double divisor, and the difference in amplitudes was measured at two wavelengths ∆P(214.5–226.0) for determination of DIPH. The developed methods have been validated as per ICH guidelines. Furthermore, the three suggested methods were employed successfully to assay marketed pharmaceutical formulation and to investigate the content uniformity of the dosage units in accordance with the United States Pharmacopeia's guidelines. Finally, the greenness profile of the proposed methods was assessed and compared with the reported method using the analytical eco-scale system, national environmental method index (NEMI), green analytical procedure index (GAPI), and analytical greenness (AGREE) metric. The results from the proposed methods statistically agreed with those obtained by the reported one, with no significant differences in accuracy and precision. Graphical Abstract

Spider diagram and sustainability evaluation of UV-methods strategy for quantification of aspirin and sildenafil citrate in the presence of salicylic acid in their bulk and formulation

“…In this paper, ASA and SIC were quantified synchronously in the presence of SA by Dual Wavelength in Ratio Spectra (DW-RS) [ 32 , 33 ] which rely on choosing two wavelengths in which the intervention component has the same absorptivities. In addition, Advanced Amplitude Centering (AAC) [ 34 , 35 ] was employed for the synchronous quantification utilizing a single divisor; supplying a favorable way to educe the target component without any interference from the escorting components in their triplex commixture.…”

A sustainable data processing approach using ultraviolet-spectroscopy as a powerful spectral resolution tool for simultaneously estimating newly approved eye solution in the presence of extremely carcinogenic impurity aided with various greenness and whiteness assessment perspectives: Application to aqueous humor

“…In this context, ultraviolet (UV)-spectrophotometric methods have been proven to be effective analytical tools and appropriate for satisfying the requirements of both the GAC and the WAC owing to their simplicity, sensitivity, selectivity, ease of use, low cost, low solvent consumption, stability, reproducibility, and eco-friendliness. 44 Therefore, the present work has four objectives. The first is to offer the first, cost-efficient, and sensitive UV-spectrophotometric approach for rapid detection and quantification of LIG, its extremely carcinogenic impurity, XYL, and FLS without any prior separation.…”