Stability Indicating RP-UPLC Photo-Diode Array based Method for Determination of Edoxaban Tosylate

Asian Journal of Organic & Medicinal Chemistry Pub Date : 2020-01-01 DOI:10.14233/ajomc.2020.ajomc-p270

D. Patel, B. Rana, S. Maru, A. Vyas, A. Patel, A.I. Patel, N. K. Patel

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引用次数: 1

Abstract

The objective of the current study was to develop a specific, precise, accurate and robust gradient stability indicating reversed-phase ultra performance liquid chromatography (RP-UPLC-PDA) assay method and validated for determination of edoxaban tosylate in API. Gradient separation was achieved on an acquity UPLC BEH C18 column (50 mm, 2.1 mm and 1.7 μm) column using mobile phase of acetoitrile:20 mM potassium dihydrogen phosphate, pH 3.0 ± 0.05 adjust with OPA at flow rate of 0.6 mL/min, the injection volume was 1 μL and the detection was carried out of 289 nm by using photodiode array detector. The drug was subjected to oxidation, hydrolysis, photolysis, and heat to apply stress condition. The method was linear in the drug concentration range of 100-300 μg/mL with correlation coefficient of 0.999. Degradation products produced as a result of stress studies did not interfere with detection of edoxaban tosylate and the assay, thus developed stability indicating method can be used for routine analysis in pharmaceutical industry.

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稳定性指示RP-UPLC光电二极管阵列测定Tosylate依多沙班的方法

本研究的目的是建立一种特异、精确、准确和稳健的梯度稳定性指示反相超高效液相色谱(RP-UPLC-PDA)测定原料药中tosy酸依多沙班的方法，并对其进行验证。色谱柱为UPLC BEH C18 (50 mm、2.1 mm和1.7 μm)，流动相为乙二腈:磷酸二氢钾20 mm, pH 3.0±0.05,OPA调节，流速0.6mL/min，进样量为1 μL，光电二极管阵列检测器在289 nm处进行检测。对药物进行氧化、水解、光解、加热等应激反应。该方法在100 ~ 300 μg/mL范围内线性良好，相关系数为0.999。应激研究产生的降解产物不干扰tosy酸乙多沙班的检测和测定，因此所建立的稳定性指示方法可用于制药工业的常规分析。

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Asian Journal of Organic & Medicinal Chemistry

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