Development and Evaluation of a Fixed-Dose Combination Tablet for Spasmodic Disorders Using Green Analytical Tools

Abstract

Mefenamic acid-containing combinations are widely used for the management of spasmodic disorders; however, their prolonged use has been associated with gastrointestinal irritation, ulceration, bleeding, and potential renal adverse effects. Therefore, the present study aimed to develop a novel fixed-dose combination containing Paracetamol, Dicyclomine Hydrochloride, and Serratiopeptidase to provide effective pain relief and antispasmodic action while potentially minimizing the risks associated with mefenamic acid therapy.. A simultaneous UV spectrophotometric method was developed for quantitative estimation of the three drugs using selected analytical wavelengths. Calibration studies showed good linearity and compliance with Beer Lambert’s law within the selected concentration ranges. The developed analytical method was found to be simple, accurate, precise, economical, and reproducible for routine pharmaceutical analysis. The environmental sustainability of the developed UV spectrophotometric method was evaluated using the Analytical GREEnness (AGREE) metric, which assesses compliance with the 12 principles of Green Analytical Chemistry. The obtained AGREE score confirmed the method's eco-friendly nature, reduced environmental impact, and suitability for sustainable pharmaceutical analysis. The developed analytical method was further evaluated using the RGB model, which comprehensively assesses analytical performance (Red), environmental friendliness (Green), and practical applicability/productivity (Blue). The RGB evaluation demonstrated an optimal balance among method effectiveness, greenness, and practical utility, confirming its suitability for routine pharmaceutical analysis.