Abstract

THE ESTIMATION OF POMALIDOMIDE IN CAPSULE DOSAGE FORMS BY RP-HPLC

Dhananjaya. G*, M. Naveen Reddy, P. Janaki Pathi, J. Raghuram and N. Appala Raju

ABSTRACT

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Pomalidomide in Capsule dosage form. Zorbax Eclipse XDB-C18, (150x4.6mm, 5μm particle size) with mobile phase consisting of Solvent-A (Buffer) is 3.48 gms of Di Potassium hydrogen ortho-phosphate (0.02M) in 1000 ml of water and by adjusting the pH to 2.5 with dilute orthophosphoric acid and Solvent-B as acetonitrile in gradient mode of elution was used. The flow rate was 1.0 mL/min and the effluents were monitored at 262 nm. The retention time was 4.4 min and run time was set for 8 minutes. The detector response was linear in the concentration of 5-60 mcg/mL. The respective linear regression equation being Y= 271612.284x+180103.1388. The limit of detection and limit of quantification was 0.5 mcg/mL and 1.5 mcg/mL respectively. The percentage assay of Pomalidomide was 99.3 %. The method was validated by determining its accuracy, precision and linearity. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Pomalidomide in bulk drug and in its pharmaceutical Capsule dosage form.

Keywords: Pomalidomide, RP-HPLC and Capsules.