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采用导数比光谱法和化学计量校准法同时定量分析药物制剂中阿托伐他汀钙和非诺贝特

Simultaneous quantitative resolution of atorvastatin calcium and fenofibrate in pharmaceutical preparation by using derivative ratio spectrophotometry and chemometric calibrations.

作者信息

Vipul Kalamkar, Rajshree Mashru

机构信息

Pharmacy Department, Faculty of Technology & Engineering, The M. S. University of Baroda Gujarat, India.

出版信息

Anal Sci. 2007 Apr;23(4):445-51. doi: 10.2116/analsci.23.445.

DOI:10.2116/analsci.23.445
PMID:17420550
Abstract

In the present work, five different spectrophotometric techniques for simultaneous determination of formulations containing atorvastatin calcium (ATOR) and fenofibrate (FENO) in various combinations are described. In ratio spectra derivative spectrophotometry, analytical signals were measured at wavelengths corresponding to either maximums or minimums for both drugs in first derivative spectra of ratio spectra obtained by using either spectrum as divisor. For the remaining four methods using chemometric techniques, namely, classical least squares (CLS), inverse least squares (ILS), principal component regression (PCR) and partial least squares (PLS), the calibrations were constructed by using the absorption data matrix corresponding to the concentration data matrix, with measurements in the range of 231 - 310 nm (Deltalambda = 1 nm) in their zero-order spectra. The linearity range was found to be 4 - 22 and 2 - 20 microg/ml for ATOR and FENO, respectively. The validity of the proposed methods was successfully assessed for analyses of both drugs in laboratory-prepared mixtures and in commercial tablet formulations.

摘要

在本研究中,描述了五种不同的分光光度技术,用于同时测定含有不同组合的阿托伐他汀钙(ATOR)和非诺贝特(FENO)的制剂。在比率光谱导数分光光度法中,通过将任一光谱用作除数获得的比率光谱的一阶导数光谱中,在对应于两种药物的最大值或最小值的波长处测量分析信号。对于使用化学计量技术的其余四种方法,即经典最小二乘法(CLS)、逆最小二乘法(ILS)、主成分回归(PCR)和偏最小二乘法(PLS),通过使用与浓度数据矩阵对应的吸收数据矩阵构建校准曲线,在其零阶光谱中测量范围为231 - 310 nm(Δλ = 1 nm)。发现ATOR和FENO的线性范围分别为4 - 22和2 - 20 μg/ml。所提出的方法在分析实验室制备的混合物和商业片剂制剂中的两种药物时均成功评估了其有效性。

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