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不同简单比值光谱处理方法在分析高浓度阿格列汀和二甲双胍复方制剂中的比较研究。

Comparative study between different simple methods manipulating ratio spectra for the analysis of alogliptin and metformin co-formulated with highly different concentrations.

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Helwan University, Ein Helwan, Cairo 11795, Egypt.

Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt; Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, Ein Helwan, Cairo 11795, Egypt; The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2017 Nov 5;186:23-28. doi: 10.1016/j.saa.2017.06.010. Epub 2017 Jun 6.

DOI:10.1016/j.saa.2017.06.010
PMID:28601548
Abstract

Different simple spectrophotometric methods were developed for simultaneous determination of alogliptin and metformin manipulating their ratio spectra with successful application on recently approved combination, Kazano® tablets. Spiking was implemented to detect alogliptin in spite of its low contribution in the pharmaceutical formulation as low quantity in comparison to metformin. Linearity was acceptable over the concentration range of 2.5-25.0μg/mL and 2.5-15.0μg/mL for alogliptin and metformin, respectively using derivative ratio, ratio subtraction coupled with extended ratio subtraction and spectrum subtraction coupled with constant multiplication. The optimized methods were compared using one-way analysis of variance (ANOVA) and proved to be accurate for assay of the investigated drugs in their pharmaceutical dosage form.

摘要

开发了不同的简单分光光度法,通过对其比值光谱进行处理,同时测定阿格列汀和二甲双胍,成功应用于最近批准的复方制剂 Kazano®片剂。尽管阿格列汀在药物制剂中的贡献较低(与二甲双胍相比,数量较少),但仍采用加标法来检测阿格列汀。使用导数比值法、比值减法结合扩展比值减法以及光谱减法结合常数乘法,分别在 2.5-25.0μg/mL 和 2.5-15.0μg/mL 的浓度范围内,可得到阿格列汀和二甲双胍的线性关系。采用单向方差分析(ANOVA)对优化后的方法进行比较,证明该方法在其药物制剂中的测定是准确的。

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