Rupatadine fumarate

A simple, rapid, sensitive and precise UV spectrophotometric method has been developed for the estimation of rupatadine fumarate from bulk drug and pharmaceutical formulation. In this method rupatadine fumarate showed maximum absorbance at about 250 nm in absolute alcohol. Beer’s law was followed in the concentration range of 1 to 30 μg/ ml. Regression equation was found to be y = 0.0257- 3x 10-5  and coefficient of correlation was 0.9999 . The proposed method is accurate, sensitive, reproducible and useful for the estimation of   rupatadine fumarate from bulk drug and pharmaceutical formulation.

A simple, rapid and accurate high performance liquid chromatography method is described for determination of rupatadine fumarate from its active pharmaceutical ingredients. The separation of drug was achieved on Inertsil ODS-3 C18 (250 X 4.6 mm) 5µ column. The mobile phase was a mixture of acetonitrile and methanol (80:20 v/v) : buffer of pH  4.5 [70:30 % v/v]. The buffer of pH 4.5 was prepared from 0.01 M ammonium acetate and pH was adjusted with dilute acetic acid. The detection was carried out at wavelength 250 nm. The mixture of water: acetonitrile (30:70 % v/v) was used as a diluent. The method was validated for system suitability, linearity, accuracy, precision, robustness, stability of sample solution. The method has been successfully used to analyze rupatadine fumarate from pharmaceutical formulation.