Development and validation of liquid chromatographic and ultraviolet derivative spectrophotometric methods for determination of epinastine hydrochloride in coated tablets.
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.
Ghisleni
Daniela Dal Molim
DD
Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, Brazil. danieladmghisleni@terra.com.br
Steppe
Martin
M
Schapoval
Elfrides E S
EE
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
D003984:Dibenzazepines; D004304:Dosage Forms; D006634:Histamine H1 Antagonists; D007093:Imidazoles; D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated; C053090:epinastine