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采用96孔板基质的绿色高通量分析法测定片剂剂型中的盐酸二甲双胍。

Green and High Throughput Assay Using 96-Microwell Base to Determine Metformin Hydrochloride in the Tablet Dosage Form.

作者信息

Alqarni Mohammed, Alshehri Atheer, Almalki Bayan, Althumali Refah, Alghamdi Maram, Alqahtani Rawan, Alotibi Safia G, Alqarni Ali, Awad Adel H, Naguib Ibrahim A

机构信息

Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.

College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.

出版信息

Int J Anal Chem. 2024 Aug 23;2024:3374034. doi: 10.1155/2024/3374034. eCollection 2024.

Abstract

Metformin (MET) is an oral antidiabetic drug widely used as the primary treatment for type 2 diabetes mellitus (T2DM). While various spectrophotometric assays exist for determining MET in pharmaceutical formulations, they often have limited throughput for quality control purposes. This study describes the validation of a 96-microwell plate spectrophotometer method using charge-transfer complexes (CTCs) with chloranilic acid (CLA) and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) for the quality control and detected of MET. This reaction was carried out in 96-microwell plates, and the absorbance of the colored complexes of CLA and DDQ were measured at 530 nm and 460 nm, respectively, using an absorbance microplate reader. This study aims to identify and quantify the use of a 96-microwell plate spectrophotometer analytical technique for assessing complicated formulations. The method was successfully used for the quantification of MET in the tablet dosage form. The results showed good correlation coefficients (0.996 and 0.997) with CLA and DDQ, respectively. The present method showed high precision with RSD % not exceeding 2.17%. The accuracy of the method was obtained by recovery percentage, with percentage values less than ±5%. The Analytical Greenness Metric (AGREE) was used to evaluate greenness of the assays. The result show that the microwell assay method is greenness and suitable for handling large samples on a daily used with high throughput analysis. The use of the 96-microwell-plate method is superior to the existing method in terms of simplicity of the procedure, the low economic cost, and its consumption of low amounts of reagents and organic ethanol solvent, making it an environmentally friendly method. Therefore, these advantages make them suitable and rapid alternatives method to current methods for routine metformin analysis in quality control laboratories.

摘要

二甲双胍(MET)是一种口服抗糖尿病药物,广泛用作2型糖尿病(T2DM)的主要治疗药物。虽然有多种分光光度法可用于测定药物制剂中的MET,但出于质量控制目的,它们的通量往往有限。本研究描述了一种96孔板分光光度计法的验证,该方法使用与氯冉酸(CLA)和2,3 - 二氯 - 5,6 - 二氰基 - 1,4 - 苯醌(DDQ)形成的电荷转移络合物(CTC)来进行MET的质量控制和检测。该反应在96孔板中进行,使用酶标仪分别在530nm和460nm处测量CLA和DDQ有色络合物的吸光度。本研究旨在鉴定和量化一种用于评估复杂制剂的96孔板分光光度计分析技术的用途。该方法成功用于片剂剂型中MET的定量。结果表明,与CLA和DDQ的相关系数分别为0.996和0.997。本方法显示出高精度,相对标准偏差(RSD)%不超过2.17%。该方法的准确度通过回收率百分比获得,百分比值小于±5%。使用分析绿色度指标(AGREE)来评估分析方法的绿色度。结果表明,微孔板测定法是绿色的,适用于日常高通量分析中处理大量样品。96孔板法在操作步骤的简便性、低经济成本以及试剂和有机乙醇溶剂消耗量低方面优于现有方法,使其成为一种环境友好的方法。因此,这些优点使其成为质量控制实验室中常规二甲双胍分析的当前方法的合适且快速的替代方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/641c/11458303/787281b097f7/IJAC2024-3374034.001.jpg

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