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Determination of mirtazapine in spiked human plasma and tablets by first derivative spectrofluorimetric method

机译:一阶导数光谱法测定加标人血浆和片剂中的米氮平

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A sensitive first derivative spectrofluorimetric method (^1D-spectrofluorimetry) was developed for the determination of mirtazapine. Calibration graph for mirtazapine determination was established using the first derivative amplitudes of the mirtazapine emission spectrum (@l"e"x=314nm) in 0.1M sulphuric acid measured at 375-435nm from peak to peak, as the analytical signals. Moreover, the ratio of ^1D-spectrophotometric peak amplitudes at these wavelengths was calculated and used for the detection of the presence of interferences. Linearity range was found to be between 1 and 40ngml^-^1 with correlation coefficient (r)=0.9999. The limit of quantitation (LOQ) was 1.0ngml^-^1 and the limit of detection (LOD) was 0.2ngml^-^1. The proposed method was validated according to ICH; and it has been applied for the drug determination in human plasma without prior extraction and in tablets. The proposed method's accuracy, reproducibility, selectivity and simplicity suggest its application in quality control analysis of the drug.
机译:建立了灵敏的一阶导数光谱荧光法(^ 1D光谱荧光法)来测定米氮平。使用在0.1M硫酸中从峰到峰在375-435nm处测得的0.1M硫酸中的米氮平发射光谱的一阶导数振幅(@“ e” x = 314nm),建立了米氮平测定的校准图。此外,计算了在这些波长下的^ 1D分光光度法峰振幅之比,并将其用于检测干扰的存在。发现线性范围在1至40ngml ^-^ 1之间,相关系数(r)= 0.9999。定量限(LOQ)为1.0ngml ^-^ 1,检测限(LOD)为0.2ngml ^-^ 1。该方法已通过ICH验证。它已被用于无需事先提取的人体血浆中和片剂中的药物测定。所提出的方法的准确性,可重复性,选择性和简单性提示其在药物质量控制分析中的应用。

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