Analytical Method Development And Validation Of Divalproex Sodium By Using RP- HPLC

Abstract

New RP HPLC method was developed for the estimation of Divalproex Sodium pharmaceutical dosage form.. Absorption maxima of the drug in UV–Visible region in different solvents/buffers was determined and different solvents were tried for HPLC method development. Mobile phase was optimized and flow rates for proper resolution and retention times. HPLC method was validated as per ICH guidelines. Among the method's many benefits are its straight forward and mobile phase, inexpensive solvents, quick analysis. HPLC system used was JASCO system equipped with model PU 4180 RHPLC pump. rheodyne sample injection port (20 µl), JASCO UV-4075 UV-VIS detector and Chrom NAVCFR chromatography software (version 2.0). Separation was carried out on HiQSil C18 (250 mm x 4.6 mm, 5 µm) column using methanol and 0.1% formic acid in water as mobile phase at flow rate of 1.0 min. Samples were injected using Rheodyne injector with 20 µL. loop. Detection was carried out at 210nm, with  a sharp peak at 4.20 minutes for divalproex sodium work .the method exhibits good linearity (r2 = 0.9999). The % RSD values for method precision and intermediate precision studies were found to be less than 2%. The % recovery was found to be within an acceptable limit 98%-102%.Thus, the created method was described as robust, accurate, exact, and linear.