Application and validation of an eco-friendly TLC-densitometric method for simultaneous determination of co-formulated antihypertensive agents

Abstract

Owing to the greater awareness that has arisen within the analytical community regarding the colossal negative influence of hazardous chemicals on both health and the environment, there is an increasing interest in developing more environment-friendly practices in different research areas. In this context, an eco-friendly TLC-densitometric method was designed, optimized and validated for the quantitative analysis of a ternary pharmaceutical mixture used for hypertension management, in the pure powdered form, synthetic mixtures and combined pharmaceutical formulation. The proposed method is based on the separation of the three co-formulated drugs; telmisartan (TL), hydrochlorothiazide (HZ) and amlodipine besylate (AM) on silica gel F₂₅₄ plates, using green solvents as the developing system. The method was validated with regard to linearity, accuracy, precision, system suitability, and robustness. Comparison of the suggested method to the reported conventional TLC-densitometric method, regarding their validation parameters and greenness profiles, was carried out. The suggested method was found to be more eco-friendly and more solvent-/time-saving; hence it can be used for quality control analysis of the studied mixture in a safer way.