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Simultaneous determination of Nebivolol hydrochloride and Valsartan in their binary mixture using different validated spectrophotometric methods.
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy ( IF 4.4 ) Pub Date : 2020-01-21 , DOI: 10.1016/j.saa.2020.118083
Esraa M Meselhy 1 , Afaf A Aboul Kheir 2 , Magda M El Henawee 2 , Manal S Elmasry 2
Affiliation  

Five simple, sensitive, accurate and precise spectrophotometric methods were developed for the simultaneous determination of Nebivolol hydrochloride (NEB) and Valsartan (VAL) in their binary mixtures and in pharmaceutical dosage form. The methods included Ratio Difference, First Derivative ratio, Mean Centering of ratio spectra, Bivariate and H-Point Standard additions method. The calibration curves were linear over the concentration range of 10-70 μg/ml and 20-60 μg/ml for NEB and VAL, respectively for Ratio Difference and First Derivative ratio method and over the concentration range of 10-70 μg/ml and 10-60 μg/ml for NEB and VAL, respectively for Mean Centering of ratio spectra, Bivariate and H-Point Standard additions method. These methods were examined by analyzing synthetic mixtures of the studied drugs and they were utilized to determine the studied drugs in their commercial pharmaceutical preparation. All methods were validated as per ICH guidelines and accuracy, robustness, repeatability and precision were found to be within the acceptable limits. The results of the proposed methods were compared to the results of reported methods with no significant difference between them.

中文翻译:

使用不同的验证分光光度法同时测定盐酸奈必洛尔和缬沙坦的二元混合物。

开发了五种简单,灵敏,准确和精确的分光光度法,用于同时测定奈比洛尔盐酸盐(NEB)和缬沙坦(VAL)的二元混合物和药物剂型。这些方法包括比率差,一阶导数比率,比率谱的平均居中,双变量和H点标准加法。对于NEB和VAL,校正曲线在10-70μg/ ml和20-60μg/ ml的浓度范围内分别是线性的,对于比率差和一阶导数比方法,在10-70μg/ ml和20-60μg/ ml的浓度范围内是线性的NEB和VAL的​​平均光谱中心,双变量和H点标准加法分别为10-60μg/ ml。通过分析研究药物的合成混合物检查了这些方法,并将它们用于确定其商业药物制剂中的研究药物。所有方法均按照ICH指南进行了验证,发现准确性,鲁棒性,可重复性和精密度均在可接受的范围内。将拟议方法的结果与报告方法的结果进行比较,两者之间无显着差异。
更新日期:2020-01-21
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