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ISSN 2063-5346
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DEVELOPMENT AND VALIDATION OF QUANTITATIVE ESTIMATION OF POMALIDOMIDE IN CAPSULE DOSAGE FORM BY RP-HPLC

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Amjad Ali M.Iqbal, Ashwini Patil, Sayali S. Gaikwad, Shakeel .A. Choudhary, Kaleem Mazhar Petkar
» doi: 10.31838/ecb/2023.12.s3.634

Abstract

Pomalidomide is a derivative of Thalidomide and marketed by Celgene and can be enclosed it under the class of medicines called as an immune-modulatory agents. Aim of this research article is to produce a gradient elution method of analysis which is simple, linear, precise, rapid and accurate for reverse phase High Performance Liquid Chromatographic method for the quantitative estimation of Pomalidomide drug in Hard Capsule dosage form using chromatographic conditions like, Kinetex Phenyl Hexyl XB-C18, (250x4.6mm, 5μm particle size) column with mobile phase consisting of Solvent-A Phosphate Buffer and Solvent-B as Methanol in gradient mode of elution was used keeping flow rate 1.0 ml/min and wavelength at 225 nm. The retention time was found to be 09-13 min for the run time 25 minutes. The method was validated by determining it’s linearity, accuracy, precision (System precision and Method precision), robustness. The detector response was linear for the concentration range of 24-36 mcg/ml. The linear regression equation found to be Y =77701X+7076.6. Most importantly results of the study proved that the proposed RP-HPLC method is useful for the routine determination of Pomalidomide in bulk drug and pharmaceutical Hard gelatin shell Capsule dosage form.

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