ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOXYLAMINE AND PYRIDOXINE BY RP-HPLC METHOD

摘要

On the basis of experimental results,the proposed method is suitable for the quantitative determination of Doxylamine and Pyridoxine in pharmaceutical dosage form.The method provides great sensitivity,adequate linearity and repeatability.The estimation of Doxylamine and Pyridoxine was done by RP-HPLC.The Phosphate buffer was pH 4.6 and the mobile phase was optimized which consists of Meoh : Phosphate buffer mixed in the ratio of 70:30 % v/v.A Symmetry C18(4.6 x 150 mm,5 μm,Make XTerra)column used as stationary phase.The detection was carried out using UV detector at 273 nm.The solutions were chromatographed at a constant flow rate of 1.0 ml/min.the linearity range of Doxylamine and Pyridoxine were found to be from 25-125 μg/ml.Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method.The percentage recovery varies from 97-102% of Doxylamine and Pyridoxine LOD and LOQ was found to be within limit.