Reversed Phase High Pressure Liquid Chromatography Technique for Validation of Rupatadine Fumarate from Active Pharmaceutical Ingredient

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.