Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.11889/8282
Title: Development and validation of a reversed-phase HPLC method for analysis of tetrahydrozoline hydrochloride in eye drop formulations
Authors: Al-Rimawi, Fuad 
Zareer, Wahbeh 
Rabie, Salah 
Quod, Mazen 
Keywords: Tetrahydrozoline;Hydrochloride;Drugs - Validation;Precision medicine;Medicine - Accuracy;Linearity
Issue Date: 2012
Publisher: Journal of Pharmaceutical Analysis
Abstract: A simple,precise,accurate,andstability-indicatingmethodisdevelopedandvalidated for analysisoftetrahydrozolinehydrochlorideineyedropformulations.Separationwasachieved on areversed-phaseC8 column (125mm 4.6 mmi.d.,5 mm) using a mobile phase consisting of acetonitrile/phosphate bufferofpH3.0(20:80,v/v)ataflowrateof1.0mL/minandUVdetection at 240nm.ThismethodisvalidatedaccordingtoUnitedStatesPharmacopeiarequirementsfor new methods,whichincludeaccuracy,precision,selectivity,robustness,andlinearityandrange. This methodshowsenoughselectivity,accuracy,precision,andlinearityandrangetosatisfy Federal DrugAdministration/InternationalConferenceonHarmonizationregulatoryrequire- ments. Thecurrentmethoddemonstratesgoodlinearityovertherangeof0.025–0.075mg/mLof tetrahydrozoline with r2 0.999. Theaveragerecoveryofthemethodis100.8%witharelative standard deviationof0.47%.Thedegreeofreproducibilityoftheresultsobtainedasaresultof small deliberatevariationsinthemethodparametersandbychanginganalyticaloperatorshas proven thatthemethodisrobustandrugged.
URI: http://hdl.handle.net/20.500.11889/8282
DOI: 10.1016/j.jpha.2011.11.001
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