一种经验证的药物制剂用高效液相色谱-荧光法测定来曲唑的无衍生化方法

Cem Kaplan, D. Unal
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引用次数: 2

摘要

建立了高效液相色谱法测定来曲唑片剂含量的方法。方法采用反相色谱柱,以乙腈-50.0 mM磷酸溶液,pH:7 (50:50, v/v),流速0.7 mL/min为荧光检测器。来曲唑具有天然的荧光性质,该分子不需要衍生化。探测器的激发波长为256 nm,发射波长为585 nm。验证了该方法的准确性、精密度、专一性、线性度和系统适宜性参数。线性范围为50 ~ 700 ng/mL。来曲唑的检出限和定量限分别为14 ~ 50 ng/mL。药物回收率为98.8%。所建立的方法已被验证,并成功地应用于原料药的片剂分析。该方法操作简便,重现性好,可用于来曲唑片剂的常规分析。
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A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation
DOI : 10.5152.IstanbulJPharm.2018.397094 A high performance liquid chromatography method has been developed for determination of letrozole in tablets. The method has developed in reverse phase column with acetonitrile-50.0 mM phosphoric acid solution, pH:7 (50:50, v/v) and 0.7 mL/min flow rate by using a fluorimetric detector. Letrozole has natural fluorescence properties, and there is no need for derivatization for this molecule. The detector was set at 256, 585 nm for excitation and emission wavelength respectively. The method was validated in accuracy, precision, specificity, linearity and system suitability parameters are studied.  The linear range was found 50-700 ng/mL. The limit of detection and quantification for letrozole was found to be 14-50 ng/mL respectively. The recovery of drug is found to be 98.8%. The developed method has been validated and successfully applied to tablet analysis of drug substance. This method is simple, reproducible and can be used safely for routine analysis of letrozole in tablets.
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