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采用导数紫外分光光度法分析格列美脲。

Analysis of glimepiride by using derivative UV spectrophotometric method.

作者信息

Altinöz S, Tekeli D

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey.

出版信息

J Pharm Biomed Anal. 2001 Jan;24(3):507-15. doi: 10.1016/s0731-7085(00)00445-3.

Abstract

Glimepiride (Amaryl), which is a new oral antidiabetic drug in the sulfonylurea class, was analysed by using second order derivative UV spectrophotometry. The quantification of glimepiride in dimethylformamide was performed in the wavelength range of 245-290 nm at N = 6, ?lambda = 21. The second order derivative spectra was calculated using peak to peak (lambdaDMF = 263.3-268.2 nm), peak to zero (lambdaDMF = 268.2 nm) and tangent (lambdaDMF = 263.3-271.8 nm) method for calibration curves, the linearity range of 1.00-500.00 microg ml(-1) by using the second order derivative UV spectrophotometric method. The developed method was applied to directly and easily to the analysis of the pharmaceutical tablet preparations. R.S.D. were found to be 4.18% (Amaryl tablet; 1 mg) and 2.21% (Amaryl tablet; 2 mg). The method was completely validated and proven to be rugged. The limit of quantitation and the limit of detection were found as 1.00 and 0.4 microg ml(-1), respectively. This validated derivative UV spectrophotometric method is potentially useful for a routine laboratory because of its simplicity, rapidity, sensitivity, precision and accuracy.

摘要

格列美脲(亚莫利)是一种新型的磺酰脲类口服抗糖尿病药物,采用二阶导数紫外分光光度法对其进行了分析。在N = 6、Δλ = 21的条件下,于245 - 290 nm波长范围内对二甲基甲酰胺中的格列美脲进行定量分析。使用峰峰值(λDMF = 263.3 - 268.2 nm)、峰谷值(λDMF = 268.2 nm)和切线法(λDMF = 263.3 - 271.8 nm)计算二阶导数光谱以绘制校准曲线,采用二阶导数紫外分光光度法时线性范围为1.00 - 500.00 μg ml⁻¹。所建立的方法可直接且简便地应用于药物片剂制剂的分析。发现相对标准偏差分别为4.18%(亚莫利片剂;1 mg)和2.21%(亚莫利片剂;2 mg)。该方法经过了全面验证,证明具有耐用性。定量限和检测限分别为1.00和0.4 μg ml⁻¹。这种经过验证的导数紫外分光光度法因其简便、快速、灵敏、精密和准确,对常规实验室具有潜在的实用性。

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