Spectrophotometric method for the determination, validation, spectroscopic and thermal analysis of diphenhydramine in pharmaceutical preparation.

摘要: Abstract A sensitive, simple and rapid spectrophotometric method was developed for the determination of diphenhydramine in pharmaceutical preparation. The based on charge-transfer complex drug, as n-electron donor, with 2,3-dichloro-5,6-dicyano-p-benzoquinone (DDQ), π-acceptor. formation this also confirmed by UV–vis, FTIR 1H NMR spectra techniques thermal analysis. proposed validated according to ICH guidelines respect linearity, limit detection, quantification, accuracy, precision, recovery robustness. linearity range concentrations found be 12.5–150 μg/mL acceptable correlation coefficients. detection quantification limits were 2.09 6.27 μg/mL, respectively. references methods applied drug syrup. This preparation analyzed an reference statistical comparison t- F-tests revealed that there no significant difference between results two mean values standard deviations at 95% confidence level.