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Avalidated non-aqueous potentiometric titrationmethod for the quantitative determination of rupatadine fromrupatadine fumarate

R.V.Rele, S.A.Sawant, R.N.Mali

A simple precise, rapid, accurate and sensitive non-aqueous potentiometric titrationmethodwas developed for quantitative determination of rupatadine as rupatadine fumarate in pharmaceutical dosage form. The titration was carried out using standardized 0.1 N perchloric acid. The proposed method was found to be precise with % RSD <1(n = 6). The method showed strict linearity (r2 > 0.99) between 20 % to 100 % of 100 mg of drug substance weight. The percentage recovery of rupatadine in the optimized method was between 98 % to 102 %. The method is also found to be rugged when checked by different analysts and using different lots of reagents and different makes of titrators.