Analytical Method Development and Validation of Droxidopa By Using HPLC Method

Abstract

A specific, accurate, precise method developed and validated for the estimation of droxidopa. By using High Performance Liquid Chromatography and chromatographic system was equipped with Inertsil column C18 column (150mm x 4.60 mm, 5µ) as stationary phase and UV detector set at 250 nm, in conjunction with a mobile phase of 0.1%v/v Triethylamine in Water 60:40% v/v ratio at a flow rate of 1.0ml/min. The described method was linear over a concentration range of 50-150 µg/ml for droxidopa. The retention time of Droxidopa is 3.33 min and %RSD less than 2.0 found for six standard replicated injections in System precision. In Method precision %Assay also found between 90-110%, the % recovery of Droxidopa were found to be 99.10% -101.01 % respectively. Method were validated for Linearity, accuracy, precision, specificity, Robustness according to ICHguidelines and can be used for analysis. So, the method can be used for routine analysis.