Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-06-05 DOI:10.1093/chromsci/bmae038

Ashok H Akabari, Harsh Gajiwala, Sagarkumar K Patel, Jasmina Surati, Divya Solanki, Ketan V Shah, Tejas J Patel, Sagar P Patel

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Abstract

The combination of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical formulations has improved type 2 diabetes management. Two chromatographic methods TLC-densitometry and RP-HPLC were developed for simultaneous quantification of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical formulations, ensuring accuracy and stability assessment. The TLC method uses a mobile phase of methanol, toluene, ethyl acetate and triethylamine (1:7:2:0.1, v/v/v/v) on TLC silica gel plates, scanned at 268 nm. The RP-HPLC method employs isocratic elution with acetonitrile and sodium acetate buffer (adjust pH 3.6 with glacial acetic acid, 60:40 v/v) on a shimpack C18 column (250 × 4.6 mm i.d., 5 μm), detected at 235 nm. Both methods offer high accuracy and reliability, making them valuable for pharmaceutical quality control. Additionally, an environmental impact assessment was conducted using eco-scale, Analytical Greenness Metric Approach, Green Analytical Procedure Index, and national environmental method index to evaluate solvent consumption, waste generation and energy usage. Statistical comparisons (t-tests and F-tests) validate the outcomes of both methods, ensuring their effectiveness in drug formulation analysis. These methods can enhance pharmaceutical quality control while fulfilling environmental responsibilities.

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采用稳定指示型 TLC-密度计和 HPLC 方法同时测定药物剂型中的替格列汀和匹格列酮并进行环保评估

将氢溴酸替尼列汀水合物和盐酸吡格列酮结合到药物制剂中可改善 2 型糖尿病的管理。本研究开发了两种色谱法：TLC-密度测定法和 RP-HPLC 法，用于同时定量测定药物制剂中的氢溴酸替格列汀水合物和盐酸吡格列酮，以确保准确性和稳定性评估。TLC 法采用甲醇、甲苯、乙酸乙酯和三乙胺（1:7:2:0.1, v/v/v/v）流动相在 TLC 硅胶板上进行，扫描波长为 268 nm。RP-HPLC 方法采用乙腈和乙酸钠缓冲液（用冰醋酸调节 pH 值为 3.6，体积比为 60:40）在 shimpack C18 色谱柱（250 × 4.6 mm i.d.，5 μm）上进行等度洗脱，检测波长为 235 nm。这两种方法都具有很高的准确性和可靠性，因此在药品质量控制方面很有价值。此外，还采用生态尺度、分析绿色度量法、绿色分析程序指数和国家环境方法指数对溶剂消耗、废物产生和能源使用进行了环境影响评估。统计比较（t 检验和 F 检验）验证了这两种方法的结果，确保了它们在药物制剂分析中的有效性。这些方法既能加强药品质量控制，又能履行环保责任。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.