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用比率光谱导数法和化学计量学方法同时分光光度法测定药物制剂中醋酸环丙孕酮和戊酸雌二醇的含量。

Simultaneous spectrophotometric determination of cyproterone acetate and estradiol valerate in pharmaceutical preparations by ratio spectra derivative and chemometric methods.

作者信息

Dinç Erdal, Yücesoy Cem, Palabiyik I Murat, Ustündağ Ozgür, Onur Feyyaz

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Ankara University, 06100 Tandoğan, Ankara, Turkey.

出版信息

J Pharm Biomed Anal. 2003 Jul 14;32(3):539-47. doi: 10.1016/s0731-7085(03)00244-9.

Abstract

Ratio spectra derivative spectrophotometry and two chemometric methods (classical least squares, CLS and inverse least squares, ILS, were proposed for the simultaneous quantitative analysis of a binary mixture consists of cyproterone acetate (CA) and estradiol valerate (EV) in the commercial pharmaceutical preparations. In the ratio spectra derivative method, linear regression equations for both drugs were obtained by measuring the analytical signals at the wavelenghts corresponding to either maximums and minimums in the first derivative spectra of the ratio spectra. In the chemometric techniques, the concentration matrix was prepared by using the synthetic mixtures containing these drugs. The absorbance matrix corresponding to the concentration matrix was obtained by measuring the absorbances at 14 wavelengths in the range 220-290 nm for the zero-order spectra. Two chemometric calibrations were constructed by using the absorbance matrix and concentration matrix for the prediction of the unknown concentrations of CA and EV in their mixture. The numerical values were calculated by using 'MAPLE V' software. The accuracy and the precision of the methods have been determined and they have been validated by analyzing synthetic mixtures containing these two drugs. The proposed methods were successfully applied to a pharmaceutical formulation, sugar-coated tablet, and the results were compared with each other.

摘要

比率光谱导数分光光度法以及两种化学计量学方法(经典最小二乘法,CLS和逆最小二乘法,ILS)被用于同时定量分析市售药物制剂中由醋酸环丙孕酮(CA)和戊酸雌二醇(EV)组成的二元混合物。在比率光谱导数法中,通过测量比率光谱一阶导数光谱中对应最大值和最小值波长处的分析信号,获得两种药物的线性回归方程。在化学计量学技术中,使用含有这些药物的合成混合物制备浓度矩阵。通过测量零阶光谱在220 - 290 nm范围内14个波长处的吸光度,获得与浓度矩阵对应的吸光度矩阵。利用吸光度矩阵和浓度矩阵构建两种化学计量学校准模型,用于预测混合物中CA和EV的未知浓度。数值通过“MAPLE V”软件计算得出。已确定这些方法的准确度和精密度,并通过分析含有这两种药物的合成混合物对其进行了验证。所提出的方法成功应用于一种药物制剂糖衣片中,并对结果进行了相互比较。

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