Title:Rapid, Simple and Low-Cost Analytical Method Development for
Quantification of Eltrombopag Olamine in Tablet Dosage by UV
Spectroscopy Method
Volume: 17
Issue: 1
Author(s): Nandan Godani and Sanjay Sharma*
Affiliation:
- Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, (Deemed to be University), Vile Parle West, Mumbai, Maharashtra, 400056, India
Keywords:
Eltrombopag Olamine, method development, analytical method, validation, UV spectroscopy, idiopathic thrombocytopenic purpura (ITP), anemia.
Abstract:
Background: Eltrombopag Olamine is a drug used to treat thrombocytopenia, a disorder
where blood platelet counts get lower and severe aplastic anemia. It serves as a thrombopoietin
receptor agonist, which give rise to platelet production in the bone marrow.
Objectives: The objective of this study is to develop a simple, specific, accurate, precise and
economical Ultraviolet spectroscopy method to estimate the amount of Eltrombopag Olamine in
bulk and tablet dosage form.
Methods: The developed method was performed using methanol for identification and physicochemical
characterization of the drug. The validation parameters like linearity, precision, accuracy,
robustness limits of detection and quantitation, and specificity were assessed as per ICH
Q2 (R2).
Results: The maximum absorbance wavelength (λmax) of the drug was found at 247 nm in
methanol. The linearity was found in the concentration range of 2-14 μg/ml with regression
equation y = 0.0619x - 0.0123 and r² = 0.999. The standard addition method was used to determine
the accuracy of the developed method. The result was found in the % recovery range of
98-99%. The precision was done on λmax with respect to the parameters such as repeatability,
intraday, and interday. The method was found to be precise as the % RSD value was found to be
<2%. The detection limit value (LOD) and quantitation limit value (LOQ) were 0.0524 μg/ml
and 0.1588 μg/ml, respectively.
Conclusion: The developed method is simple, economical, accurate and selective. The developed
method was adaptable for the estimation of Eltrombopag Olamine analysis in pharmaceutical
dosage form and routine quality control laboratory.
