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.
