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Abstract

DEVELOPMENT AND VALIDATION FOR DETECTION OF DIC AND IHC IN ELTROMBOPAG OLAMINE TABLET BY RP-HPLC METHOD

Madasu Raja Kumar*, Samson Isreal and V. V. Nageswara Rao

ABSTRACT

An accurate and precise HPLC method was developed for the determination of DIC and IHC in Eltrombopag Olamine tablet. Separation of the drug was achieved on a Develosil ODS-MG- 3100×4.6 mm 3μ column using a mobile phase consisting of 10mM Phosphate buffer (pH 6.0): Acetonitrile: water. The flow rate was 6.0 mL/min and the detection wavelength was 254 nm. The linearity was observed in the range of 15-150 ppm for DIC and IHC with a correlation coefficient of 0.997and 0.996 respectively. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of DIC and IHC in Eltrombopag Olamine tablet.

Keywords: HPLC method, Eltrombopag Olamine tablet, Method Validation, DIC (Dimethyl Isopropyl Carboxylic acid) and IHC (Isopropyl Hydroxy Carboxylate).


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