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

摘要

Two simple titrimetric methods are described for the detn. 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 detd. by titrating with an aq. NaOH soln. 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 detn. of PAM in tablets, injections, and the results were found to be in a good agreement with those obtained by the ref. method. The precision results, expressed by intra-day and inter-day relative std. 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 mixt. analyses and also by the recovery study via std. addn. technique with percentage recoveries in the range 97.48 - 106.3% with a std. deviation of 1.76 - 3.42%. [on SciFinder(R)]