title: Development and validation of liquid chromatographic and ultraviolet derivative spectrophotometric methods for determination of epinastine hydrochloride in coated tablets.
abstract: High-performance liquid chromatographic (LC) and ultraviolet derivative spectrophotometric (UVD) methods were developed and validated for the quantitative determination of epinastine hydrochloride in coated tablets. LC was performed on a reversed-phase RP-18 column with a mobile phase composed of 0.3% triethylamine (pH adjusted to 4.0 with 10% orthophosphoric acid)-methanol (60 + 40, v/v). The first-order derivative method was performed at 243.8 nm using HCI and methanol as the solvent. The methods were validated according to U.S. Pharmacopoeia and International Conference on Harmonization guidelines. The statistical analysis by Student's t-test showed no significant difference between the results obtained by the 2 methods. The proposed methods were found to be simple, rapid, precise, accurate, robust, and sensitive, allowing perfect interchange. The LC and UVD methods can be used in the routine quantitative determination of the epinastine hydrochloride in coated tablets.
authors.affiliation: Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, Brazil. danieladmghisleni@terra.com.br
authors.forename: Daniela Dal Molim
authors.initials: DD
authors.lastname: Ghisleni
authors.forename: Martin
authors.initials: M
authors.lastname: Steppe
authors.forename: Elfrides E S
authors.initials: EE
authors.lastname: Schapoval
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002853:Chromatography, Liquid / Q000295:instrumentation* / Q000379:methods*; D003984:Dibenzazepines / Q000032:analysis*; D004304:Dosage Forms; D004355:Drug Stability; D006634:Histamine H1 Antagonists / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D007093:Imidazoles / Q000032:analysis*; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013608:Tablets, Enteric-Coated; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D003984:Dibenzazepines; D004304:Dosage Forms; D006634:Histamine H1 Antagonists; D007093:Imidazoles; D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated; C053090:epinastine