Stability Indicating RP-HPLC Method for Quantitative Estimation of Eribulin Mesylate in Eribulin Mesylate Parenteral Dosage Form

A precise, accurate and selective stability-indicating reverse phase high performance liquid chromatographic assay method has been developed for the quantitative estimation of Eribulin in Eribulin mesylate in parenteral dosage form. Samples are analysed by means of reverse phase (RP-HPLC) using stationary phase Waters X-Bridge Shield RP18 (150 x 4.6 mm, 3.5μ) and the mobile phase consisted of pH 6.5 phosphate buffer and acetonitrile in the ratio of (70:30 volume/volume). The column temperature was maintained at 40°C and sample cooler temperature was maintained at 5°C, injection volume 10 μL, flow rate 0.8 mL/min and wavelength 200 nm, run time 25 minutes. The retention time of Eribulin mesylate was noted to be 10.45 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible and consistent.