Spectrophotometric method for the determination, validation, spectroscopic and thermal analysis of diphenhydramine in pharmaceutical preparation.
A sensitive, simple and rapid spectrophotometric method was developed for the determination of diphenhydramine in pharmaceutical preparation. The method was based on the charge-transfer complex of the drug, as n-electron donor, with 2,3-dichloro-5,6-dicyano-p-benzoquinone (DDQ), as pi-acceptor. The formation of this complex was also confirmed by UV-vis, FTIR and (1)H NMR spectra techniques and thermal analysis. The proposed method was validated according to the ICH guidelines with respect to linearity, limit of detection, limit of quantification, accuracy, precision, recovery and robustness. The linearity range for concentrations of diphenhydramine was found to be 12.5-150 microg/mL with acceptable correlation coefficients. The detection and quantification limits were found to be 2.09 and 6.27 microg/mL, respectively. The proposed and references methods were applied to the determination of drug in syrup. This preparation were also analyzed with an reference method and statistical comparison by t- and F-tests revealed that there was no significant difference between the results of the two methods with respect to mean values and standard deviations at the 95% confidence level.
Ulu
Sevgi Tatar
ST
Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, 34416 Istanbul, Turkey. sevgitatar@yahoo.com
Elmali
Fikriye Tuncel
FT
D000042:Absorption; D002152:Calorimetry, Differential Scanning; D004155:Diphenhydramine / Q000032:analysis* / Q000737:chemistry; D007202:Indicators and Reagents / Q000737:chemistry; D057230:Limit of Detection; D009682:Magnetic Resonance Spectroscopy; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents / Q000737:chemistry; D013053:Spectrophotometry / Q000379:methods*; D013056:Spectrophotometry, Ultraviolet; D017550:Spectroscopy, Fourier Transform Infrared; D013696:Temperature; D013818:Thermogravimetry; D013997:Time Factors
D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations; D012997:Solvents; D004155:Diphenhydramine