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采用不同验证的分光光度法同时测定盐酸奈比洛尔和缬沙坦的二元混合物。

Simultaneous determination of Nebivolol hydrochloride and Valsartan in their binary mixture using different validated spectrophotometric methods.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo 11829, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2020 Apr 5;230:118083. doi: 10.1016/j.saa.2020.118083. Epub 2020 Jan 21.

Abstract

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.

摘要

开发了五种简单、灵敏、准确和精确的分光光度法,用于同时测定盐酸奈必洛尔(NEB)和缬沙坦(VAL)在其二元混合物和药物制剂中的含量。这些方法包括比值差法、一阶导数比值法、比值光谱的均值中心化法、双变量法和 H 点标准加入法。对于比值差法和一阶导数比值法,NEB 和 VAL 的校准曲线在 10-70μg/ml 和 20-60μg/ml 的浓度范围内呈线性关系;对于比值光谱的均值中心化法、双变量法和 H 点标准加入法,NEB 和 VAL 的校准曲线在 10-70μg/ml 和 10-60μg/ml 的浓度范围内呈线性关系。这些方法通过分析研究药物的合成混合物进行了检验,并用于测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,其准确性、稳健性、重复性和精密度均在可接受范围内。所提出的方法的结果与已报道的方法的结果进行了比较,两者之间没有显著差异。

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