Analytical Method Development and Validation for the Test Related Substances of Pomalidomide in Pomalidomide Capsules


Authors : Nilesh Kamble; Dr. A. R. Chabukswar

Volume/Issue : Volume 7 - 2022, Issue 5 - May

Google Scholar : https://tinyurl.com/32khhahj

Scribd : https://tinyurl.com/3bvvwkrf

DOI : https://doi.org/10.5281/zenodo.10071203

Abstract : The percent impurities of pomalidomide in capsules of 1mg, 2mg, 3mg, and 4mg were determined using an HPLC technique. The current study provides the pomalidomide method validation for related chemicals test's procedural design and acceptance criteria. On a 1 mg capsule, the following tests were performed: force degradation, LOD, and LOQ, linearity and range, accuracy, solution stability, filter study, specificity, and robustness. On the pomalidomide capsules, precision and intermediate precision were also conducted. The study's output cleared that method is easy, quick, specific & accurate, making it suitable for regular pomalidomide determination in bulk and pharmaceutical dose forms.

Keywords : Pomalidomide; HPLC; Method validation; Capsules.

The percent impurities of pomalidomide in capsules of 1mg, 2mg, 3mg, and 4mg were determined using an HPLC technique. The current study provides the pomalidomide method validation for related chemicals test's procedural design and acceptance criteria. On a 1 mg capsule, the following tests were performed: force degradation, LOD, and LOQ, linearity and range, accuracy, solution stability, filter study, specificity, and robustness. On the pomalidomide capsules, precision and intermediate precision were also conducted. The study's output cleared that method is easy, quick, specific & accurate, making it suitable for regular pomalidomide determination in bulk and pharmaceutical dose forms.

Keywords : Pomalidomide; HPLC; Method validation; Capsules.

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