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首页> 外文期刊>Journal of Young Pharmacists >Development of a Rapid RP-HPLC Method for Simultaneous Determination of Metformin and Vildagliptin in Formulation and Human Plasma
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Development of a Rapid RP-HPLC Method for Simultaneous Determination of Metformin and Vildagliptin in Formulation and Human Plasma

机译:同时测定配方和人血浆中二甲双胍和维格列汀的快速RP-HPLC方法的建立

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Objective: The objective of the proposed method was to develop a simple, fast, sensitive, and validated high-performance liquid chromatography (HPLC) method for the simultaneous estimation of metformin and vildagliptin in tablets and human plasma. Materials and Methods: The chromatographic separation was accomplished with a fast monolithic column using a mixture of sodium dihydrogen phosphate and sodium dodecyl sulfate and acetonitrile at pH 4.5 as the mobile phase. In addition, newly developed method was validated as indicated by International Conference on Harmonization guidelines. Results: The method showed good correlation coefficients (r ≥ 0.997) in the range of 0.05-20 μg/mL and 0.1-40 μg/mL for metformin and vildagliptin, respectively. The accuracy and intraday and interday precision results were within the acceptable range for both analytes. The mean extraction recoveries of metformin and vildagliptin from human plasma were 97.51% and 97.18%, respectively. Conclusion: The simple, rapid, sensitive, robust and validated analytical method developed was used for simultaneous estimation of metformin and vildagliptin in formulation and in patient plasma.
机译:目的:该方法的目的是开发一种简单,快速,灵敏且经过验证的高效液相色谱(HPLC)方法,用于同时估算片剂和人血浆中的二甲双胍和维达列汀。材料和方法:用快速整体柱色谱分离,使用磷酸二氢钠和十二烷基硫酸钠和乙腈的混合物(pH为4.5)作为流动相。另外,国际协调会议指南指出,新开发的方法已经过验证。结果:该方法在二甲双胍和维达列汀的0.05-20μg/ mL和0.1-40μg/ mL范围内显示出良好的相关系数(r≥0.997)。两种分析物的准确度以及日内和日间精密度结果均在可接受的范围内。人血浆中二甲双胍和维达列汀的平均提取回收率分别为97.51%和97.18%。结论:开发的简单,快速,灵敏,鲁棒且经过验证的分析方法用于同时评估制剂和患者血浆中的二甲双胍和维达列汀。

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