Method development and validation for simulataneous estimation of albendazole and praziquantel in bulk and in a synthetic mixture

Abstract

A simple, rapid, sensitive reversed-phase high-performance liquid chromatography method was developed and validated for simultaneous measurement of albendazole and praziquantel with an internal standard, simvastatin, at single wavelength of 225 nm. Chromatographic separation was performed on an Enable C18 column (250 mm × 4.6 mm, 5 μm: Spinco Biotech Pvt Ltd) and a mobile phase consisting of acetonitrile:water (60:40, v/v) with 10% orthophosphoric acid to adjust the pH to 3.2, at a flow rate of 1.0 ml/min. The calibration curve was linear (r2 ≥ 0.999) over the concentration range 0.05–8.0 μg/ml. The concentrations of simvastatin was 1.0 μg/ml. The limit of quantification was 0.05 μg/ml for both albendazole and praziquantel. No interference was found by the excipients in the synthetic mixture. The proposed methods were validated as per International Conference on Harmonisation guidelines for linearity, accuracy, precision and robustness for estimation of albendazole and praziquantel in bulk and in a synthetic mixture, and the results were found to be satisfactory.