国际药物开发与研究杂志

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Analytical Method Development and Validation of Pheniramine Maleate Injection

Yasir Mehmood, Noviara Saleem, Rana Khalid Mahmood, Humayun Riaz and Syed Atif Raza

Pheniramine Maleate assay in its injection formulation was performed using spectrophotometric estimation in UV/Vis-region and non-aqueous titration method. The method have been developed and validated in spectrophotometric Method and water was used as diluent which does not shows any interference in spectrophotometric estimations. ICH guidelines were used to determine the analysis parameter. RSD and %RSD were obtained statistically along with neat chromatograms. Precision and accuracy of the results were obtained also which showed that the method is very accurate for quantitative estimation of Pheniramine Maleate in injection dosage forms. Another simple titrimetric method is described for the determination of Pheniramine Maleate (PM) in pure form and in injection dosage forms. The principle involved in the method is simple acid-base reaction in which the perchloric acid is used as titrant and naphthol benzene as indicator.