Smart green spectrophotometric estimation and content uniformity testing of chlorphenoxamine HCl and caffeine in bulk forms and combined pharmaceutical formulation

Chlorphenoxamine hydrochloride is a chemical that has attracted interest because of its notable anti-histaminic and anti-cholinergic characteristics. Moreover, it has been recognized as a highly efficient tool in the fight against several lethal viral diseases, such as Severe Acute Respiratory Syndrome Coronavirus. In this study, five efficient and straightforward univariate spectrophotometric approaches are proposed for accurately measuring the quantities of Caffeine and Chlorphenoxamine HCl in bulk forms and combined pharmaceutical formulations. Notably, these methods based on an advanced approach using the factorized response spectrum and not require any initial processing.They have been classified into three spectrophotometric platform windows. The study of Window I focuses on absorption spectra of substances in their original states(zero-order). It includes, absorbance resolution method (AR), extended absorbance difference method (EAD), and factorized zero order method (FZM). Window II focuses on the factorized derivative method (FDM), while Window III focuses on factorized ratio difference method (FRM). These approaches successfully measured concentration of Caffeine and Chlorphenoxamine HCl within a range of 3-35.0 and 3-45.0 μg/mL, respectively. The factorized response spectrum's exclusivity stems from its capacity to fully separate the mentioned components in mixture and recover the pure spectra. Validation of the suggested approaches has been conducted according to guidelines established by International Council for Harmonization, which demonstrated acceptable levels of accuracy and precision. The scope of this work has been expanded to include verification of content uniformity of dosage units according to recommendations outlined in United States Pharmacopoeia. Greenness profile of the proposed approaches has been properly assessed using state-of-the-art software metrics, in comparison to the reported one. Finally, the proposed methods demonstrated strong compliance with the recently established principles of white field of analytical chemistry.

Caffeine; Chlorphenoxamine HCl; Content uniformity test; Factorized response spectrum; Whiteness assessment.