A Novel Spectrophotometric Method Development for Quantification of Desidustat in Bulk and Pharmaceutical Dosage Form

Abstract

Background: Desidustat (DES) belongs to a new category of drugs, i.e., Hypoxia-Inducible Factor (HIF) propyl hydroxylase inhibitor, and is used for the treatment of anemia in chronic kidney disease. However, no method has yet been reported in the literature for the estimation of drugs. Objective: The objective of the study is to develop a simple, precise, and accurate method for determining DES in bulk and pharmaceutical dose form. Methods: The stability-indicating HPLC method for assay included the use of Kromasil 100-5-C8 (100 mm × 4.6 mm) column, UV detector 224 nm, mobile phase composition involving a mixture of acetonitrile:water (52:48), and a flow rate of 1.0 mL/min. ICH guidelines were followed for the method's validation. To assess the method's specificity and stability in showing characteristics, stress degradation studies were carried out. The working standard solution of dapagliflozin was exposed to 1 and 2 N HCl by refluxing 1 and 2 N NaOH with 30% hydrogen peroxide by volume and UV radiation in order to conduct a degradation study. Results: Maximum absorbance wavelength was observed at 229 nm. The sample solution remained stable for up to 12 hours. The linear response from 2 to 12 μg/ml of DES was y = 0.1087x + 0.0962 and r2 = 0.9963. The accuracy was between 100 to 101%. Precision was recorded under three criteria: repeatability, intraday and interday, for which results fell within the acceptable ranges (<2%). The limit of detection (LOD) and limit of quantification (LOQ) of the technique were 0.434 μg/ml and 1.316 μg/ml, respectively. Conclusion: The proposed method was found to be beneficial for drug monitoring and the ongoing analysis of DES in research and quality control laboratories. This approach is simple, precise, rapid, economical, and sensitive