RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF AZELNIDIPINEAbstract
A simple and precise method was developed for the assay of azelnidipine from tablet formulation. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method, azelnidipine shows the maximum absorbance at 257 nm. The separation was achieved on HPLC binary gradient system equipped with HPLC 3000 series. The mobile phase was prepared with Methanol: Water (80: 20%v/v) o-phosphoric acid used for the pH adjustment (pH-3). The method was validated for accuracy, precision, linearity, LOD & LOQ of sample solution. Linearity was observed in the concentration range of 20-100 µg/ml & gave mean correlation coefficient 0.998. The developed RP-HPLC method was found to be accurate, precise and was successful applied to a pharmaceutical tablet formulation for qualitative estimation of Azelnidipine.