Ecofriendly Chromatographic Assay of Metformin Combinations; Content Uniformity Tests and Toxicity Profiling.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2024-07-10 DOI:10.1093/chromsci/bmad026

Aml A Emam, Eglal A Abdelaleem, Fatma Magdy, Ahmed M Gouda, Fatma F Abdallah

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Abstract

Accurate, sensitive and green HPTLC chromatographic method was proposed for simultaneous determination of metformin, glipizide and sitagliptin in the presence of metformin potential toxic impurities melamine and cyanoguanidine. The separation was completed on silica gel HPTLC F254 plates using a mixture of ethyl acetate: methanol: ammonia: formic acid (7: 2: 0.2: 0.2, by volume) as a developing system with UV scanning for the developed bands at 235 nm. The Rf values for metformin, glipizide, sitagliptin, melamine and cyanoguanidine were 0.17, 0.84, 0.67, 0.47 and 0.75, respectively. Linear responses were observed in the ranges of 0.2-3, 0.07-1.5, 1.5-5, 0.8-4 and 0.4-2 μg/band with correlation coefficients of 0.9999, 0.9998, 0.9997, 0.9996 and 0.9998 for metformin, glipizide, sitagliptin, melamine and cyanoguanidine, respectively. The proposed method was validated as per ICH criteria with respect to linearity, accuracy, precision, specificity and robustness. The validated method was successfully applied for determination of the studied drugs in Janumet® and Engilor® tablets; also, the results were statistically compared to those obtained by the reported spectrophotometric method and no significant difference was found between them. This method permitted the accurate simultaneous determination of the studied drugs, indicating its ability to be used for routine quality control assays of these drugs.

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二甲双胍复方制剂的生态友好型色谱分析；含量均匀性测试和毒性分析。

提出了同时测定二甲双胍、格列齐特和西他列汀中二甲双胍潜在毒性杂质三聚氰胺和氰胍的准确、灵敏和绿色的HPTLC色谱法。采用乙酸乙酯：甲醇：氨水：甲酸（体积比为 7：2：0.2：0.2）的混合物作为显色体系，在硅胶 HPTLC F254 板上完成分离，在 235 纳米波长处对显色条带进行紫外扫描。二甲双胍、格列齐特、西他列汀、三聚氰胺和氰胍的 Rf 值分别为 0.17、0.84、0.67、0.47 和 0.75。二甲双胍、格列齐特、西格列汀、三聚氰胺和氰胍在0.2-3、0.07-1.5、1.5-5、0.8-4和0.4-2 μg/带范围内呈线性关系，相关系数分别为0.9999、0.9998、0.9997、0.9996和0.9998。该方法在线性、准确度、精密度、特异性和稳健性方面均符合 ICH 标准。该方法成功地测定了 Janumet® 和 Engilor® 片剂中的药物含量，并将测定结果与已报道的分光光度法进行了统计比较，未发现两者之间存在显著差异。该方法可准确地同时测定所研究的药物，表明它可用于这些药物的常规质量控制检测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.