Development and Validation of a UV Spectroscopic Method to Estimate Eltrombopag Olamine along with Bulk and In-house Formulation

Abstract

The current UV Spectroscopic method developed involving ethanol as a solvent is simple, fast, specific, precise, and sensitive for the estimation of Eltrombopag Olamine in bulk in day-to-day analysis. As per the ICH Q2 (R1) guideline, the method was validated. Eltrombopag Olamine is a drug used to treat thrombocytopenia (a low blood platelet count) in adults and youngsters with chronic immune idiopathic thrombocytopenic purpura that didn't get well with different treatments. Eltrombopag Olamine is additionally accustomed to treating severe aplastic anemia. It’s conjointly being studied within the treatment of different conditions and kinds of cancer. Eltrombopag Olamine binds to the thrombopoietin receptor, which causes the bone marrow to create more platelets. It’s class of thrombopoietin receptor agonists, also known as Promacta. Eltrombopag is also recently approved (2012) for the treatment of thrombocytopenia in a patient with chronic hepatitis C to start and sustain interferon-based therapy. The solvent used in the entire method development and validation was ethanol. The maximum wavelength of absorption was found to be 423nm. Beer’s law was obeyed in the concentration range of 5 to 30ug/ml with a correlation coefficient of 0.9966. The method was precise with an RSD of less than 2%, the LOD, and LOQ were found to be 6.18ug/ml and 18.7ug/ml respectively, % recovery of the drug is 98 to 100%. The method was validated for linearity, precision, accuracy, and robustness and all parameters were found to be satisfactory which proves that this method can be used for routine analysis of Eltrombopag Olamine.