Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DESIDUSTAT IN TABLET DOSAGE FORM

Riya Patel* and Priyanka Yadav

ABSTRACT

A Specific, sensitive, accurate, precise and robust isocratic RP-HPLC method was Developed and validated for Desidustat, using Thermofisher C18 (150mm*4.6mm) 5μm column with flow rate 1.0ml/min and Detection Wavelength of 235 nm. The mobile phase is ACN + 0.1% Formic Acid (80:20%v/v) and injection volume is 20μl, total run time 15 min. Detection carried out at 235nm wavelength. The stability indicating capability of method was established by forced degradation studies of bulk and pharmaceutical dosage form. The developed method was validated as per International Conference of Harmonization (ICH) for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. Stability Indicating Study suggested that major degradation of bulk was observed in Thermal condition and form was observed in Oxidative condition. Correlation co-efficient for calibration curve of Desidustat was found to be 0.999. The RSD for precision and robustness was found < 2.

Keywords: Desidustat, Stability, Erythropoietin, Forced degradation study.