Quantitative Analysis of Dimetindene Maleate in Dosage Forms by Ion-pair Reversed- Phase HPLC

Abstract

The formulations of Dimetindene Maleate as capsule, drop and gel and their methods of analysis are still unavailable in international Pharmacopeia. In this work ion-pair reversed- phase HPLC method was developed for the determination of Dimetindene Maleate in its dosage forms, which can be used for the assay of capsule or tablet, drop and gel. The separation of Dimetindene Maleate was performed in about 10 minutes with high efficiency using ODS column 25cm and a mobile phase consists of methanol 40 % in distilled water containing 0.02% 1-heptane sulfonate and adjusted with sulfuric acid to pH (3.5).The linearity of this HPLC method was proved and a straight line relationship was obtained between the peak areas and the different concentrations of Dimetindene Maleate standard solution in the range (1-8)μg/ml with confidence limit of 0.998 and the RSD was not more than 1.2%. In addition, this method was found to be suitable for stability study of dimetindene preparations and for dissolution test of capsules and tablets of dimetindene as well.

Keywords

• Dimetindene Maleate, HPLC