STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ELTROMBOPAG OLAMINE IN TABLET DOSAGE FORM BY RP-UPLC

Abstract

A simple, precise, and accurate stability indicating isocratic Reverse Phase Ultra-PerformanceLiquid Chromatographic (RP-UPLC) method was developed for quantitative determination of Eltrombopagolamine in the presence of degradant products. The method was developed using Acquity UPLC BEH C18(50 × 2.1 mm, 1.7 μm) column with mobile phase containing water (adjusted to pH 3 with formic acid)and acetonitrile in the ratio of 30:70. The eluted compound was monitored at 244 nm and run time waswithin 2 min. Eltrombopag olamine was subjected to the stress condition of oxidative, acid, base, thermal,and photolytic degradation. The drug was found to degrade significantly in acid, base, and oxidative stresscondition and stable in thermal and photolytic degradation conditions. The degradation products were wellresolved from the main peak, providing stability indicating power of the method. The developed methodwas validated as per ICH Q2(R1) guideline with linearity range was between 25-75 μg/mL,% recoveryrange was found as 99.8-101.9 and precision was found as RSD less than 2.