Reverse Phase High Performance Liquid Chromatography for Validation of Epinastine Hydrochloride in Bulk and Pharmaceutical Dosage Form

Abstract

The validation method of epinastine hydrochloride from combined dosage form i.e. eye drops was described by high performance liquid chromatography method with separation of drugs on Water symmetry RP18 (150 x 4.6 mm i.d.) and 5 µ particle size. A mixture of buffer and acetonitrile (73:27 % (v/v)) was constituted as mobile phase. The chromatograms were studied at 220 nm as wavelength. The mobile phase was also used as a diluent. A validated of method was studied for linear regression, accuracy, method as well as system precision. The robustness study was done for change in wavelength, mobile phase composition and flow rate as per ICH guidelines. The method has been successfully used to analyze epinastine hydrochloride from dosage form i.e. eye drops.