HPLC method development and validation for the simultaneous estimation of alvimopan in bulk and pharmaceutical dosage form

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of alvimopan in bulk and capsule dosage form. A column of Altima 150mm x 4.6 mm, 5µ was used. The mobile phase comprises of potassium dihydrogen orthophosphate buffer and acetonitrile in the ratio of 60:40 (v/v). The flow rate was 1.0 ml/min and the effluents were monitored at 260 nm. The retention time was found to be 4.001. The detection concentration was linear over 30-180ppm.Regression equation of alvimopan was found to be y = 6065.6x + 795.43with regression co-efficient 0.999. The developed method was successfully validated in accordance to ICH guidelines. Hence, this method can be conveniently adopted for the routine analysis in quality control laboratories.