Initial-rate method for the determination of pantoprazole in pharmaceutical formulations using 1-fluoro 2,4-dinitrobenzene.
A simple and selective kinetic spectrophotometric method for the determination of pantoprazole in pharmaceutical preparations is described. The procedure is based upon a kinetic investigation of the reaction of the drug with 1-fluoro-2,4-dinitrobenzene in DMSO at room temperature. The absorbance of the coloured product was measured at 420 nm. The plot of the logarithm of the initial rate of the reaction vs. the logarithm of molar concentration of pantoprazole is linear over the range 10-20 microg x ml(-1). The procedure retains its accuracy in the presence of a large excess of its degradate, sulfenic acid, which is prepared by degradating the pure drug in borate buffer of pH 8 at room temperature for seven days. The results are validated statistically and through recovery studies. The method has been successfully applied to the determination of pantoprazole in commercial tablets. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.
Rahman
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Analytical Research Laboratory, Department of Chemistry, Aligarh Muslim University, Aligarh, UP, India. cht17nr_amu@yahoo.com
Kashif
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D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000465:Algorithms; D000897:Anti-Ulcer Agents / Q000032:analysis*; D001562:Benzimidazoles / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002855:Chromatography, Thin Layer; D004121:Dimethyl Sulfoxide; D004139:Dinitrofluorobenzene; D004304:Dosage Forms; D007202:Indicators and Reagents; D007700:Kinetics; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000032:analysis*; D000077402:Pantoprazole; D012015:Reference Standards; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013454:Sulfoxides / Q000032:analysis*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D004304:Dosage Forms; D007202:Indicators and Reagents; D012997:Solvents; D013454:Sulfoxides; D004139:Dinitrofluorobenzene; D000077402:Pantoprazole; D009853:Omeprazole; D004121:Dimethyl Sulfoxide