Spectrophotometric Determination of Olopatadine Hydrochloride in Eye Drops and Tablets

Abstract

Optimized and validated three UV spectrophotometric methods have been proposed for the determination of olopatadine hydrochloride in different dosage forms (eye drop and tablets) and bulk drug. The developed methods viz. linear regression equation (LRE), standard absorptivity (SA) and first order derivative (FOD) method were validated for linearity, accuracy, precision and robustness according to ICH guideline to assure reliability of the developed methods. The methods follow Beer-Lambert's law for the concentration of 10-50 μg mL -1 . Validated methods were applied for determination of olopatadine hydrochloride content in tablet dosage forms as well as in eye drops with non-significant difference (P > 0.05) and can be successfully applied for routine analysis like assay, dissolution studies, bio-equivalence studies etc. in pharmaceutical industries.