High Performance Liquid Chromatographic Determination of Butamyrate Citrate in Pharmaceutical Preparation

An HPLC method was developed and validated for the determination of butamyrate citrate. The HPLC separation was achieved on a diol column (300 × 4.6 mm) packed with 5.0 μm particle size using a mobile phase of ammonium acetate buffer (pH = 6.5) and methanol (750:250, v/v) at a flow rate of 1.4 ml min-1. The UV detector was operated at 225 nm. The method was validated for specificity, linearity, precision, accuracy and robustness. The retention time was 5.9 min. The proposed method provided linear responses within the concentration range 75-225 μg ml-1 with LOD and LOQ values of 0.69 and 2.29 μg ml-1, respectively. Correlation coefficient (r) of the regression equation was 0.9999. The method was found to be precise, accurate, and reproducible