Estimation of pomalidomide in capsule dosage form by RP-HPLC

A simple, precise, rapid and accurate RPHPLC method was developed for the estimation of Pomalidomide (PML) in capsule dosage forms. An XTerra RP C18, (250 x 4.6 with 5 microns particle size) and the mobile phase, consisting of 0.03M KH2PO4 in water adjusting the pH-3.2 with O-Phosphoric Acid: Acetonitrile in ratio of 20:80 v/v & Acetonitrile HPLC Grade: Water HPLC Grade (50:50 v/v) was used as diluent in the gradient mode. The flow rate was 0.7 ml/min and the effluents were monitored at 220 nm. The retention time was 5.219 for PML. The detector response was linear in the concentration of 7.4 -88.8 μg/mL for PML. The respective linear regression equation being Y (-504143.1912) = 171820.582x + 1730704.1677 for PML. The Limit of Detection (LOD) is 0.074 & The Limit of Quantification (LOQ) is 0.222 for PML respectively. The % assay of PML was found out to be 99.66%. The method was validated by determining its accuracy, precision and system suitability. 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 PML in bulk drug and in its pharmaceutical dosage forms.