Development and validation of related substances method for Varenicline and its impurities

摘要

A simple and accurate reverse phase HPLC method has been developed and validated for quantification of Varenicline and its related impurities in bulk drug and pharmaceutical dosage form. Separation was achieved on c18 column by mobile phase consisted phosphate buffer with pH 3.0 and acetonitrile and flow rate 1.0ml/min. The detection wavelength was set at 235nm. The method was linear at concentration range from LOQ to 150% of specification level. The limit of quantification and limit of detection values less than 20% of specification level. Method precision and ruggedness the relative standard deviations did not exceed 2%. The accuracy of the method proved, the mean recovery between 85 to 115%. The results demonstrated that the method would have a great value when applied in quality control and stability studies for Verenicline.