Advancements in the Analytical Methods for Ripasudil Hydrochloride Hydrate and Timolol Maleate: A Recently Approved FDC

Abstract

Fixed-dose combinations (FDCs) combine two or more medications into a single dosage form. Several benefits, including impending therapeutic efficacy, a decline in episodes of adverse drug effects, pharmacokinetic advantages, a decrease in pill burden, a reduction in the dose of individual medications, and a reduction in the emergence of drug resistance, justify their acceptance. For the treatment of increased intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, an FDC eye drop formulation, including ripasudil hydrochloride hydrate (0.4%W/V) and timolol maleate (0.5%W/V) has just received approval. No analytical method has been reported thus far for this newly approved combination. Thus, this review collected and simplified information on reported analytical techniques and physicochemical and biological properties for the above-cited FDCs. The authors have explored various authenticated scientific journals and presented simplified information to meet the objectives. In this study, the reported methods are spectroscopy (nil, 23%), HPTLC (nil, 10%), HPLC (100%, 61%), hyphenated techniques (nil, 6%) and electrophoresis methods (nil, 6%) for ripasudil hydrochloride hydrate and timolol maleate, respectively. Analysts using such comprehensive data might develop a method for analyzing the recently approved FDCs.