Title:Advancements in the Analytical Methods for Ripasudil Hydrochloride
Hydrate and Timolol Maleate: A Recently Approved FDC
Volume: 19
Issue: 6
Author(s): Khushbu Patel and Rajendra Kotadiya*
Affiliation:
- Department of Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and
Technology, Changa, Dist-Anand, Gujarat, India
Keywords:
Analytical methods, chromatography, FDC, green chemistry, spectroscopy, intraocular pressure.
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.
