Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.
Saudi Pharm J. 2010 Jan;18(1):45-9. doi: 10.1016/j.jsps.2009.12.006. Epub 2010 Jan 6.
A sensitive first derivative spectrofluorimetric method ((1)D-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 (λ ex = 314 nm) in 0.1 M sulphuric acid measured at 375-435 nm from peak to peak, as the analytical signals. Moreover, the ratio of (1)D-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 40 ng ml(-1) with correlation coefficient (r) = 0.9999. The limit of quantitation (LOQ) was 1.0 ng ml(-1) and the limit of detection (LOD) was 0.2 ng ml(-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.
建立了一种灵敏的一阶导数荧光光谱法（1D 光谱法），用于测定米氮平。通过测量米氮平在 0.1M 硫酸中在 314nm 处的发射光谱（λex=314nm）的一阶导数幅度（在 375-435nm 处从峰到峰），建立了米氮平的校准曲线，作为分析信号。此外，还计算了这些波长处的（1）光谱光度峰值幅度比，并用于检测干扰物的存在。线性范围为 1 至 40ngml(-1)，相关系数（r）=0.9999。定量限（LOQ）为 1.0ngml(-1)，检测限（LOD）为 0.2ngml(-1)。根据 ICH 对该方法进行了验证；并已应用于未经提取的人血浆和片剂中药物的测定。该方法的准确性、重现性、选择性和简单性表明其可应用于药物的质量控制分析。
