Abstract

METHOD DEVELOPMENT AND VALIDATION OF REGORAFENIB BY RP-HPLC METHOD IN PURE FORM AND PHARMACEUTICAL DOSAGE FORM

Santhosh Illendula*, Konda Mounika, Dr. K. Rajeshwar Dutt

ABSTRACT

A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Regorafenib in bulk and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5μm, 15cm x 4.6mm i.d. column with UV detection at 257 nm and Acetonitrile : Methanol = 70:30 (pH-3.6) ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Regorafenib in bulk and pharmaceutical dosage form. The method was linear over the range of 30-70μg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.007 μg/ml and quantification was found to be 0.026 μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.

Keywords: RP-HPLC, Regorafenib, Method development and validation, ICH Guidelines.