Quantitative Estimation of Eltrombopag in Bulk and Tablet Dosage Form by UV- Spectroscopy

The present work aimed to develop a straightforward, simple and cost-effective UV Spectroscopic technique employing methanol and water (1:1) as a solvents. The method focused on a simple, rapid, specific, accurate, precise, and selective approach in the estimation of Eltrombopag in bulk and tablet dosage form for routine analysis. The ICH Q2 (R1) guideline was followed during method development and validation. Eltrombopag is the drug of choice in the treatment of thrombocytopenia and severe aplastic anemia. Eltrombopag is a BCS Class II medication that is sparingly soluble in water and has a pKa of about 3.5. Its solubility varies with pH, becoming more soluble at lower pH levels and more soluble in the organic solvent methanol. The method utilizes water and methanol (1:1), with a maximum absorption wavelength detected at 245nm. The method is specific; no interference with blank and placebo. Linearity in the concentration range of 1.00 to 40.00 µg/mL, exhibiting a high correlation coefficient of 0.999. Precision was demonstrated with an RSD below 2%, while LOD and LOQ were determined as 1.5µg/mL and 4.51µg/mL respectively. The drug recovery rate falls within the range of 99.94 to 100.65%. The solution was stable for 24hours at room temperature condition. The parameters validated were precision, linearity, accuracy, robustness and specificity as per ICH guidelines were found to be satisfactory for the routine analysis of Eltrombopag by UV spectroscopy.