RAPID AND SENSITIVE UPLC-MS/MS VALIDATED METHOD FOR ELTROMBOPAG DETERMINATION IN HUMAN PLASMA AND ITS APPLICATION TO BIOEQUIVALENCE STUDY | ||||
| Egyptian Journal of Applied Science | ||||
| Volume 37, Issue 11, November 2022, Page 34-48 PDF (729.73 K) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/ejas.2022.283066 | ||||
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| Abstract | ||||
| ABSTRACT A rapid, simple, sensitive, reproducible, and reversed-phase UPLC-MS/MS method was established and validated for determining eltrombopag in human plasma. Eltrombopag was extracted from plasma samples by the protein precipitation technique using acetonitrile. Eltrombopag was separated on a C18- column of Acquity UPLC BEH adjusted at 35°C and mass analysed in a positive electrospray ionization mode. A simple mobile phase of formic acid (0.1%) and acetonitrile in a 25:75 (v/v) ratio was utilized at a flow rate of 400 μL min-1. The analysis of eltrombopag was carried out within 2 min over a broad range between 50 and 10000 ng mL-1 (mean r2 = 0.9937). Accuracy ranged from 102.70 to 111.43%, whereas the precision (inter- and intra-assay) was not more than 15%. The results confirmed the eltrombopag stability under various conditions. The proposed and validated method was effectively applied to a bioequivalence study of eltrombopag tablet (50 mg) in healthy Egyptian volunteers (n = 31). | ||||
| Keywords | ||||
| Key Words: Eltrombopag; UPLC-MS/MS; Human plasma; Bioequivalence; Incurred sample reanalysis | ||||
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