Acid-base titrimetric assay of pheniramine maleate in pharmaceuticals in hydro-alcoholic medium

摘要

Two simple titrimetric methods are described for the determination of pheniramine maleate (PAM) in pure form and in its dosage forms. The principle involved in the methods are simple acid-base reaction in which the carboxylic acid group of the drug was determined by titrating with an aqueous NaOH solution either visually using phenolphthalein as indicator (method A) or pH-metrically (method B) using glass-calomel electrode system. The methods were applicable over the range of 2-20 mg of PAM. The procedures were applied to the determination of PAM in tablets, injections, and the results were found to be in a good agreement with those obtained by the reference method. The precision results, expressed by intra-day and inter-day relative standard deviation values, were satisfactory (RSD ≤ 2.58%). The accuracy was satisfactory as well (RE ≤ 2.14%). Excipients used as additives in pharmaceutical formulations did not interfere in the proposed procedures as shown by placebo blank and synthetic mixture analyses and also by the recovery study via standard addition technique with percentage recoveries in the range 97.48 – 106.3% with a standard deviation of 1.76 - 3.42%.