一阶导数紫外光谱法测定盐酸芬氟拉明片的含量及含量均匀度
Determination of fenfuramine hydrochloride tablets with first order derivative spectrophotometry
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摘要: 目的 建立一阶导数紫外光谱法测定盐酸芬氟拉明片的含量及含量均匀度,以增加质量控制方法。方法 用水作溶剂,在280与220nm波长范围内测定一阶导数光谱,以一阶导数光谱在265nm与269nm波长处峰-谷间的振幅D为定量依据,用对照品对照法计算含量及含量均匀度。结果 盐酸芬氟拉明浓度在0.05～0.4mg/ml之间与-阶导数峰-谷间的振幅呈良好的线性关系,相关系数r=0.9999,6次的平均加样回收率为100.6%,RSD=0.7%.结论 本法准确性和重现性好,操作简便、快速。Abstract: OBJECTIVE To provide a useful way of quality control,a first order derivative spectrophotometric method had been developed to determine the content and uniformity of content of fenfuramine hydrochloride tables.METHODS Water was selected for solvent.The first derivative spectrum was obtained by scanning from 280 to 220nm.The distance D of the derivative peak at 265nm and valley at 295nm was used as quantitative basis.The assay was calculated by comparing the peak-valley distance of sample with standard.RESULTS There was a good linear relationship between fenfuramine hydrochloride concentration in the range of 0.05～0.40mg/ml and the peak-valley distance of derivative spectrum with r=0.9999.The average recovery form sample was 100.6%. RSD=0.7%(n=6).CONCLUSIONS The proposed method is simple,accurate and reproducible.
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