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开发用于测定氨氯地平苯磺酸盐和新一代他汀类药物在新复方制剂中含量的光谱数值因子技术。

Developing spectral numerical factor technique for the determination of amlodipine besylate and the latest generation of statins in their new pharmaceutical combination.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo, Egypt; Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Science and Pharmaceutical Industries, Future University, Cairo, Egypt.

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

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2019 Jul 5;218:320-330. doi: 10.1016/j.saa.2019.04.017. Epub 2019 Apr 11.

Abstract

Spectral numerical factor techniques have been developed for quantification of a new pharmaceutical combination. Five simple, fast and accurate spectrophotometric methods using spectral factor manipulation have been tested and validated so as to determine quantitatively a new fixed-dose combination tablet containing both amlodipine besylate (ADB) and rosuvastatin calcium (ROS). Namely, these methods are induced dual wavelength, absorbance correction, absorbance subtraction, amplitude correction and advanced amplitude subtraction. Their corresponding spectral factors are equality, absorption, absorbance, amplitude and unity factor, respectively. Calibration curves of ADB and ROS were set up for all the previously mentioned methods under the optimum conditions in a concentration range of 3.0-21.0 μg/mL with correlation coefficients ≥0.9990. Selectivity was calculated by analyzing laboratory-prepared synthetic blends of the cited drugs. A comparative study between these methods and the reported ones has been carried out statistically forming a judgment that the difference between both results is totally insignificant. Actually, the suggested spectral factor technique is so effective for use in routine laboratory essay owing to its simplicity, rapidity and precision. Generally, the proposed factor procedures have the ability to run smoothly without any interference from additives that may deteriorate analysis efficiency of a pharmaceutical combination.

摘要

光谱数值因子技术已被开发用于定量新的药物组合。已经测试和验证了五种简单、快速和准确的分光光度法,使用光谱因子处理来定量测定含有苯磺酸氨氯地平(ADB)和瑞舒伐他汀钙(ROS)的新固定剂量组合片剂。这些方法分别为双波长诱导、吸光度校正、吸光度差、幅度校正和先进的幅度差减法。它们对应的光谱因子分别为相等、吸收、吸光度、幅度和单位因子。在最佳条件下,对所有上述方法在 3.0-21.0μg/mL 的浓度范围内建立了 ADB 和 ROS 的校准曲线,相关系数≥0.9990。通过分析实验室制备的混合药物进行了选择性计算。对这些方法和已报道的方法进行了统计学比较研究,结果表明两者之间的差异完全不显著。实际上,由于其简单、快速和精确,所建议的光谱因子技术非常适用于常规实验室试验。一般来说,所提出的因子程序能够顺利运行,不会受到可能降低药物组合分析效率的添加剂的干扰。

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