Development and validation of a novel stability indicating HPLC method for the separation and determination of darolutamide and its impurities in pharmaceutical formulations

Bulletin of the Karaganda University. "Chemistry" series Pub Date : 2021-12-30 DOI:10.31489/2021ch4/57-68

V. Kamani, M. Sujatha, G. Daddala

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Abstract

This study reports for the first time about a stability indicating RP-HPLC method for analysis of darolutamide and its impurities 1, 2, and 3 in bulk and formulations. The separation was achieved on Phenomenex column with Luna C18 (250 mm × 4.6 mm, 5 μm) as stationary phase, and 50 mM ammonium acetate: methanol solution 15:80 (v/v) at pH 5.2 as mobile phase at 1.0 mL/min flow rate. UV detection was carried at wavelength of 239 nm. In these conditions the retention time of darolutamide and its impurities 1, 2, and 3 was 7.05, 8.90, 4.63 and 5.95 min, respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability, and robustness. Forced degradation study was done through exposure of the analyte to five different stress conditions and the % degradation was small in all degradation condition. The proposed method can separate and estimate the drug and its impurities in pharmaceutical formulations. Hence, the developed method was suitable for the quantification of darolutamide and can separate and analyse impurities 1, 2, and 3

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一种新的稳定性指示高效液相色谱分离测定药物制剂中达罗卢胺及其杂质的方法的建立和验证

本研究首次建立了一种稳定性指示型RP-HPLC方法，用于分析达鲁他胺及其杂质1、2、3的原料药和制剂。采用Phenomenex色谱柱进行分离，固定相为Luna C18 (250 mm × 4.6 mm, 5 μm)，流动相为50 mm乙酸铵:甲醇溶液15:80 (v/v)， pH 5.2，流速1.0 mL/min。紫外检测波长为239 nm。在此条件下，达鲁他胺及其杂质1、2、3的保留时间分别为7.05、8.90、4.63、5.95 min。验证了该方法的系统适用性、分析范围、精密度、特异性、稳定性和鲁棒性。通过将分析物暴露于5种不同的应力条件下进行强制降解研究，在所有降解条件下，降解率都很小。所提出的方法可以分离和估计药物制剂中的药物及其杂质。因此，所建立的方法适用于达鲁他胺的定量分析，可以对杂质1、2、3进行分离分析

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Bulletin of the Karaganda University. "Chemistry" series

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