稳定性指示一阶导数同步荧光光谱法测定新批准抗病毒药物Daclatasvir的氧化和光解降解产物:在片剂剂型中的应用

R. El-Gamal, F. Belal
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引用次数: 3

摘要

建立了一阶导数同步荧光光谱法测定盐酸daclatasvir (DCV)氧化和光解降解产物的含量,方法灵敏、简便、快速。其中同步一阶导数荧光光谱法用于在373 nm处定量测定氧化降解产物的DCV,以及在388 nm处通过将DCV暴露在312 nm的紫外光下获得的光解降解产物,这些是无干扰的降解产物的零交叉波长。在Δ λ (80 nm)处进行同步荧光扫描。该方法在0.5 ~ 5.0 ng/mL浓度范围内呈线性关系,检测下限为0.090,定量下限分别为0.275 ng/mL (373 nm)和0.268 ng/mL (388 nm)。所采用的方法成功地应用于商品片剂,结果表明,导数同步荧光光谱法是一种稳定性指示方法,适合在短时间内常规使用。对该方法进行了线性、准确度、精密度、特异性和鲁棒性验证。
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Stability Indicating 1st Derivative Synchronous Spectrofluorimetric Method for the Determination of the Newly Approved Antiviral Drug Daclatasvir in Presence of Its Oxidative and Photolytic Degradation Products: Application to Tablet Dosage Form
A highly sensitive, simple and rapid first derivative synchronous spectrofluorimetric method was utilized for the determination of daclatasvir dihydrochloride (DCV) in presence of its oxidative and photolytic degradation products. Where synchronous 1st derivative spectrofluorimetric approach was utilized to quantitatively determine DCV at 373 nm in presence of its oxidative degradation product and at 388 nm in presence of its photolytic degradation product that is obtained by exposing DCV to UV light at 312 nm, these were the zero-crossing wavelengths of degradation products without interference. The synchronous fluorescence was scanned at Δ λ of 80 nm. The method was found to be linear across the concentration range of 0.5-5.0 ng/mL with lower detection limit of 0.090 and lower quantification limit of 0.275 ng/mL (at 373 nm) and 0.268 ng/mL (at 388 nm). The adopted approach was successfully applied to commercial tablet and the results exhibited that the derivative synchronous fluorescence spectroscopy is a stabilityindicating method, suitable for routine use within a short analysis time. The proposed method was carefully validated for linearity, accuracy, precision, specificity and robustness.
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