Abdelwahab Nada S, El-Zeiny Badr A, Tohamy Salwa I
Beni-suif University, Faculty of Pharmacy, Department of Analytical Chemistry, Egypt.
Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562 Cairo, Egypt.
J Pharm Anal. 2012 Aug;2(4):279-284. doi: 10.1016/j.jpha.2012.02.002. Epub 2012 Feb 21.
Two simple, accurate, precise and economic spectrophotometric methods have been developed for simultaneous determination of Atorvastatin calcium (ATR) and Ezetimibe (EZ) in their bulk powder and pharmaceutical dosage form. Method (I) is based on dual wavelength analysis while method (II) is the mean centering of ratio spectra spectrophotometric (MCR) method. In method (I), two wavelengths were selected for each drug in such a way that the difference in absorbance was zero for the second drug. At wavelengths 226.6 and 244 nm EZ had equal absorbance values; therefore, these two wavelengths have been used to determine ATR; on a similar basis 228.6 and 262.8 nm were selected to determine EZ in their binary mixtures. In method II, the absorption spectra of both ATR and EZ with different concentrations were recorded over the range 200-350, divided by the spectrum of suitable divisor of both ATR and EZ and then the obtained ratio spectra were mean centered. The concentrations of active components were then determined from the calibration graphs obtained by measuring the amplitudes at 215-260 nm (peak to peak) for both ATR and EZ. Accuracy and precision of the developed methods have been tested; in addition recovery studies have been carried out in order to confirm their accuracy. On the other hand, selectivities of the methods were tested by application for determination of different synthetic mixtures containing different ratios of the studied drugs. The developed methods have been successfully used for determination of ATR and EZ in their combined dosage form and statistical comparison of the developed methods with the reported spectrophotometric one using and Student's -tests showed no significant difference regarding both accuracy and precision.
已开发出两种简单、准确、精密且经济的分光光度法，用于同时测定阿托伐他汀钙（ATR）和依折麦布（EZ）的原料药及药物剂型。方法（I）基于双波长分析，而方法（II）是比率光谱分光光度法的平均中心化（MCR）方法。在方法（I）中，为每种药物选择两个波长，使得第二种药物的吸光度差值为零。在波长226.6和244 nm处，EZ具有相等的吸光度值；因此，这两个波长已用于测定ATR；基于类似的基础，选择228.6和262.8 nm来测定其二元混合物中的EZ。在方法II中，记录不同浓度的ATR和EZ在200 - 350范围内的吸收光谱，除以ATR和EZ的合适除数的光谱，然后将得到的比率光谱进行平均中心化。然后根据通过测量ATR和EZ在215 - 260 nm（峰到峰）处的振幅获得的校准曲线来确定活性成分的浓度。已测试所开发方法的准确性和精密度；此外，还进行了回收率研究以确认其准确性。另一方面，通过应用于测定含有不同比例研究药物的不同合成混合物来测试方法的选择性。所开发的方法已成功用于测定其复方剂型中的ATR和EZ，并且使用方差分析和学生t检验将所开发的方法与报道的分光光度法进行统计比较，结果表明在准确性和精密度方面均无显著差异。
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