Reversed phase high performance liquid chromatography method for determination of olopatadine hydrochloride from active pharmaceuticaldosage form

摘要

A simple, rapid and accurate high performance liquid chromatography method is described for determination of olopatadine hydrochloride from active pharmaceutical ingredients. The separation of drug was achieved on chromatopak peerless basic C18 (50 x 4.6 mm i.d.) with 3 mu; particle size column showed most favorable chromatographic pattern over the other columns. The mobile phase consisted of a mixture of buffer and acetonitrile (70:30 v/v). The buffer was mixtures of 0.01 tri-ethyl amine adjusted the pH 3.3 with ortho-phosphoric acid. The detection was carried out at wavelength 220 nm. The mixture of water and acetonitrile (50:50 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 olopatadine hydrochloride from active pharmaceutical ingredients.