DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR DETERMINATION OF ERDAFITINIB IN MARKETED FORMULATIONS

M. Maithani; D. Dwivedi; D.  Hatwal; P. Bansal

doi:10.32553/jbpr.v9i3.755

M. Maithani Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
D. Dwivedi Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
D. Hatwal Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
P. Bansal Multidisciplinary Research Unit, Guru Gobind Singh Medical College, Faridkot, India

DOI: https://doi.org/10.32553/jbpr.v9i3.755

Abstract

A simple and precise RP-HPLC method for the estimation of Erdafitinib in tablet dosage form was developed and validated. The chromatographic separation of the drug was done with a Hypersil™ ODS C18 Column (150 mm × 4.6 mm i.d., particle size 5 μ) using 20mM sodium acetate buffer (pH 4. ±0.02), methanol and acetonitrile (60:10:30 v/v/v) as a mobile phase. The instrument was set at flow rate of 1.0 mLmin^-1 at ambient temperature and the wavelength of UV-visible detector at 310nm. The method showed excellent linearity over a range of 5-35 μgmL^-1for the drug. The correlation coefficient for Erdafitinib was noted to be 0.9999. The mean recovery values were found to be 99.77% and 100.88%. The results suggest that the proposed method could be suitable for quantitative determination of Erdafitinib in pharmaceutical preparations and also for quality control in bulk manufacturing. The F-test and t-test at 95% confidence level were applied on data for statistical analysis.