title: First-order derivative UV spectrophotometric method for simultaneous measurement of delapril and manidipine in tablets.
abstract: A first-order derivative spectrophotometric (1D-UV) method was developed and validated for simultaneous determination of delapril (DEL) and manidipine (MAN) in tablets. The 1D-UV spectra were obtained using change lambda = 4.0 nm and wavelength set at 228 nm for DEL and 246 nm for MAN. The method was validated in accordance with the ICH requirements, involving the specificity, linearity, precision, accuracy, robustness and limits of detection and quantitation. The method showed high specificity in the presence of two drugs and formulation excipients and was linear over the concentration range of 18-54 microg mL(-1) (r2 = 0.9994) for DEL and 6-18 microg mL(-1) (r2 = 0.9981) for MAN with adequate results for the precision (< or = 1.47%) and accuracy (98.98% for DEL and 100.50% for MAN). Moreover, the method proved to be robust by a Plackett-Burman experimental design evaluation. The proposed 'D-UV method was successfully applied for simultaneous analysis of DEL and MAN in tablets and can be used as alternative green method to separation techniques. The results were compared with the validated liquid chromatography, capillary electrophoresis and liquid chromatography-tandem mass spectrometry methods, showing non-significant difference.
authors.affiliation: Postgraduate Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, 90610-000 Porto Alegre-RS, Brazil. vitor_todeschini@hotmail.com
authors.forename: Vítor
authors.initials: V
authors.lastname: Todeschini
authors.forename: Amanda Thomas
authors.initials: AT
authors.lastname: Barden
authors.forename: Leticia Lenz
authors.initials: LL
authors.lastname: Sfair
authors.forename: Maximiliano
authors.initials: M
authors.lastname: da Silva Sangoi
authors.forename: Nadia Maria
authors.initials: NM
authors.lastname: Volpato
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000032:analysis*; D002121:Calcium Channel Blockers / Q000032:analysis*; D002853:Chromatography, Liquid; D004095:Dihydropyridines / Q000032:analysis*; D007189:Indans / Q000032:analysis*; D057230:Limit of Detection; D009578:Nitrobenzenes; D010879:Piperazines; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D053719:Tandem Mass Spectrometry
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D007189:Indans; D009578:Nitrobenzenes; D010879:Piperazines; C054218:manidipine; C047759:delapril