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A validated simple titrimetric method for the quantitative determination of rupatadine as rupatadine fumarate from pharmaceutical dosages

R.V.Rele, S.A.Mahimkar, S.A.Sawant

A simple precise, rapid accurate and sensitive titration method was developed for quantitative determination of rupatadine as rupatadine fumarate in pharmaceutical dosage form. The titrationwas carried out using standardized 0.1 N sodium hydroxide solution. 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 98.51 % to 100.269 %. The method is also found to be rugged when checked by different analysts and using different lots of reagents and different laboratories.