Open AccessDevelopment and Validation of Stability Indicating RP-UPLC Method for the Estimation of Pomalidomide in Bulk and Pharmaceutical Dosage Form
Author(s) -
D. Suchitra,
AUTHOR_ID,
B. Satyanarayana,
AUTHOR_ID
Publication year - 2022
Publication title -
ymer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.103
H-Index - 5
ISSN - 0044-0477
DOI - 10.37896/ymer21.02/25
Subject(s) - chromatography , high performance liquid chromatography , forced degradation , acetonitrile , active ingredient , elution , pharmaceutical formulation , linearity , chemistry , materials science , reversed phase chromatography , pharmacology , medicine , physics , quantum mechanics
The present research work is mainly focussed on development of a novel, rapid, accurate and stability indicating UPLC method by using an advanced separation technique called Ultra Performance Liquid Chromatography, for the quantitative analysis of Pomalidomide in bulk and pharmaceutical dosage forms. This is a modified form of HPLC technique in which there is a significant increase in sensitivity, resolution and rapidity. The operation was carried out on a Waters Acquity UPLC instrument. Data acquisition and processing was done using Empower 2 software. The drug was eluted on an Acquity BEH C18 (50×2.1mm id, 1.7µm) analytical column with mobile phase containing 0.01M Potassium dihydrogen orthophosphate (adjusted to pH 3.5 using 0.1% dilute orthophosphoric acid (30%): Acetonitrile (70%). 0.3ml min-1 flow rate was maintained and the study was performed at 225nm using TUV detector. The drug was found to be retained at 1.682min. The number of theoretical plates and asymmetry was also found to be within the acceptance criteria. Method validation was carried out according to the ICH guidelines and the parameters namely- accuracy, precision, linearity, robustness, ruggedness, specificity, LOD and LOQ were studied. It was found that 5-30µg/ml was the linearity range and all other parameters result were found to be within the limits. Pomalidomide drug was stressed to acid, alkali, oxidative, thermal, hydrolytic and photolytic degradation and the results revealed that the developed method was capable to segregate all the degraded products from the active pharmaceutical ingredient. Hence this method can be used for routine quality estimation of drug analysis.