Akabari Ashok H, Gajiwala Harsh, Patel Sagarkumar K, Surati Jasmina, Solanki Divya, Shah Ketan V, Patel Tejas J, Patel Sagar P
Department of Quality Assurance, Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh, Gujarat, India.
Labcorp Drug Development Inc, Somerset, New Jersey-08873 USA.
J Chromatogr Sci. 2025 Jan 14;63(2). doi: 10.1093/chromsci/bmae038.
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.
氢溴酸替格列汀水合物与盐酸吡格列酮在药物制剂中的组合改善了2型糖尿病的管理。开发了两种色谱方法，即薄层色谱 - 密度测定法和反相高效液相色谱法，用于同时定量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。薄层色谱法在硅胶薄层板上使用甲醇、甲苯、乙酸乙酯和三乙胺（1:7:2:0.1，v/v/v/v）的流动相，在268 nm处进行扫描。反相高效液相色谱法在shimpack C18柱（250×4.6 mm内径，5μm）上采用乙腈和乙酸钠缓冲液（用冰醋酸调节pH值至3.6，60:40 v/v）等度洗脱，在235 nm处检测。这两种方法都具有很高的准确性和可靠性，使其在药物质量控制中具有重要价值。此外，还使用生态规模、分析绿色度指标方法、绿色分析程序指数和国家环境方法指数进行了环境影响评估，以评估溶剂消耗、废物产生和能源使用情况。统计比较（t检验和F检验）验证了两种方法的结果，确保了它们在药物制剂分析中的有效性。这些方法可以在履行环境责任的同时加强药物质量控制。
