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诱导数学过滤作为固定剂量复方中血糖控制药物鉴别和估计的创新策略。

Induced mathematical filtration as an innovative strategy for discrimination and estimation of glycemic control drugs in fixed dose combination.

作者信息

Lotfy Hayam M, Mohamed Ekram H

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Science & Pharmaceutical Industries, Future University in Egypt, 12311, Cairo, Egypt.

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, 11837, El-Sherouk City, Cairo, Egypt.

出版信息

Heliyon. 2020 Oct 24;6(10):e05289. doi: 10.1016/j.heliyon.2020.e05289. eCollection 2020 Oct.

Abstract

An innovative strategy was developed for the estimation of a fixed dose combination containing Alogliptin (ALO) and pioglitazone (PIO) using induced concept for resolving the overlapped spectra, lacking isoabsorptive point. This strategy is based on coupling factors as numerical values or ratios as spectrum form with the recorded signals leading to induced mathematical filtration of the drug of interest and complete elimination of the interfering one in the combination without prior physical separation. The calculated factors were factor of equality in induced dual wavelength (IDW) or absorptivity factor in induced concentration subtraction method (ICS) while absorptivity ratio spectrum for induced amplitude modulation method (IAM). The calibration curves displayed linearity within 1.0-16.0 μg/mL for ALO and 2.0-22.0 μg/mL for PIO with good correlation coefficients. The induced methods specificity was also assured through the assaying different synthetic mixtures prepared to contain the two drugs in ratios approaching the ratio actually found in the marketed dosage form. The methods were applicable and suitable for estimating ALO and PIO in both bulk form and their fixed dose combination. Induced methods have been extensively validated in accordance with ICH guidelines and results demonstrated the accuracy and reproducibility in comparison to the reported method.

摘要

开发了一种创新策略,用于估算含有阿格列汀(ALO)和吡格列酮(PIO)的固定剂量组合,该策略采用诱导概念来解析重叠光谱,且不存在等吸收点。该策略基于耦合因子,这些因子以数值或比率的形式作为光谱形式,并与记录信号相结合,从而对目标药物进行诱导数学过滤,并在不进行预先物理分离的情况下完全消除组合中的干扰药物。计算得到的因子在诱导双波长(IDW)中为相等因子,在诱导浓度减法法(ICS)中为吸光系数因子,而在诱导幅度调制法(IAM)中为吸光率光谱。校准曲线在1.0 - 16.0μg/mL范围内对ALO呈线性,在2.0 - 22.0μg/mL范围内对PIO呈线性,相关系数良好。通过测定不同的合成混合物,这些混合物中两种药物的比例接近市售剂型中实际发现的比例,从而确保了诱导方法的特异性。这些方法适用于估算原料药形式的ALO和PIO及其固定剂量组合。诱导方法已按照ICH指南进行了广泛验证,结果表明与报道的方法相比,该方法具有准确性和可重复性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7454/7591735/bedea9a7e201/gr1.jpg

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