Development and Validation of UV-Spectrophotometric Method Towards Determination of Ripasudil Hydrochloride Hydrate in Pure and Ophthalmic Formulation.

The goal of the present investigation was to develop and validate the UV-spectrophotometric technique for the quantitative estimation of ripasudil hydrochloride hydrate in pure and ophthalmic formulations. Ripasudil hydrochloride hydrate is a novel drug molecule that has been used to treat glaucoma and ocular hypertension. It was licensed for therapy in Japan for the first time in September 2014. Until now, only an HPLC analytical method for determining it in dosage forms and biological fluids has been disclosed. The objective of this research was to screen a solvent system in which ripasudil hydrochloride hydrate can be completely solubilized, then develop and validate a simple, accurate, precise, and cost-effective UV-spectrophotometric method for estimating ripasudil hydrochloride hydrate in the pure and ophthalmic formulations in accordance with International Conference on Harmonization (ICH) recommendations. The current method is simple, quick, accurate, precise, and cost-effective. Ripasudil hydrochloride hydrate is soluble in HPLC-grade distilled water, so it was used as a solvent to form the solution. The subsequent solution was scanned within the UV range (200–400 nm). The λmax of ripasudil hydrochloride hydrate was found to be 278 nm. Beer's law is valid within the 10 to 50-μg/mL concentration range. The developed analytical approach was extensively validated as per ICH guidelines for linearity, accuracy, precision, robustness, detection limit, and quantitation limit. Linearity was obtained within the 10 to 50-μg/mL range with a correlation coefficient of 0.9981. Limit of detection and limit of quantitation were found to be 0.0785 and 0.2355 μg/mL. The technique presented good recovery and reproducibility; thus, the proposed technique might be employed for regular investigation of ripasudil hydrochloride hydrate in the pure and ophthalmic formulations. [ABSTRACT FROM AUTHOR]