DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE DETERMINATION OF ALVIMOPAN IN BULK AND PHARMACEUTICAL FORMULATION

Objective: The present investigation demonstrates a simple, sensitive and accurate high-pressure liquid chromatographic (HPLC) method for the determination of Alvimopan (AMP) in bulk and dosage form. The chromatographic separation was achieved within 10 minutes by using acetonitrile: potassium dihydrogen phosphate buffer pH 3.0 adjusted with orthophosphoric acid (50:50) as mobile phase on Altima Grace Smart C-18 column (5μ; 250 × 4.6 mm) at flow rate of 1.0 ml/min with injection volume 20µL at wavelength of 261nm. The retention time of the drug was found to be 5.02 min. This method was validated as per United States Food & Drug Administration (US-FDA) guidelines. The results of the validation parameters were found to be within the acceptance limits. The method was linear in the concentration range from 500-20000 ng/mL (r² = 0.9998) and the accuracy of drug was found to be 95.83-104.63% for AMP. The lower limit of quantification was found to be ng/ml and the stability of recovered samples at different conditions was found to be more than 95%. The developed method possesses good selectivity, specificity, there was no interference found in the blank sample at retention times of AMP. We found a good correlation between the peak area and concentration of the drug under prescribed conditions. Furthermore, the method can also be used to estimation of drug in the dosage form for future studies of AMP.