ISSN : 2663-2187

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF DESIDUSTAT IN BULK DRUG AND FORMULATION

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Rajendra D. Dighe , Gaurav S. Deore, Ganesh B. Sonawane, Vinod A. Bairagi
» doi: 10.48047/AFJBS.6.7.2024.2893-2911

Abstract

Desidustat is Zydus Cadila's low-dose oral drug designed to treat chronic kidney disease (CKD), coronavirus, and anemia. Prolyl hydroxylase (HIF-PH) is a hypoxia-inducible nuclear factor. Desidustat inhibits the catalytic domain of prolyl hydroxylase and modulates erythropoietin growth and hypoxia-stimulated erythropoiesis-stimulated variable. A specific, sensitive, accurate, and reliable isocratic RP-HPLC method was validated for determination using a thermos fisher C18 particle size analysis column (250 mm x 4.6 mm). A mobile phase of methanol and water (30:70 v/v) at a 0.1 mL/min flow rate was used to prepare the sample. The column temperature and vehicle model are set to ambient conditions. The temperature was 25 3 °C, the injection volume was 20 microliters, and the detector wavelength was 232 nm. The forced degradation of multiple species and drug doses is necessary for this method to demonstrate stability. According to the International Conference on Harmonization (ICH), the developed method was validated for specificity, linearity, precision, accuracy, reliability, limit of detection, and limit of quantification. Stability studies show that major mass degradation occurs under thermal and

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