Development and validation of high performance liquid chromatographic method for the analysis of divalproex sodium

Abstract

A high performance liquid chromatography method has been developed for the analysis of divalproex sodium in bulk and in its tablet formulation and spiked human plasma. The method utilized a Kromosil C18 reversed-phase analytical column (250 x 4.6 mm, particle size 5 µm) with 0.1% orthophosphoric acid and methanol (50:50 v/v) as mobile phase. The analysis was performed at 30⁰C temperature with a flow rate of 1 ml/min and detection at 246 nm. The method was validated for specificity, sensitivity, precision, linearity, accuracy, selectivity and robustness. The method was found to be linear in the range between 6 μg/ml and 200 μg/ml with a correlation coefficient of 0.9998. The detection and quantitation limits obtained for DS were 0.298 μg/ml and 0.903 μg/ml, respectively. The specificity of the method was established through stress degradation studies. The results of stress degradation studies signify the stability indicating nature of the method. The developed method was applied effectively to tablet formulation and spiked human plasma without interference from the common excipients in tablets and endogenous substances in plasma.