Alqarni Mohammed, Alshehri Abdullah A, Arida Hassan
Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.
Department of Clinical Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.
Int J Anal Chem. 2024 Feb 27;2024:8664723. doi: 10.1155/2024/8664723. eCollection 2024.
Metformin is an oral biguanides hypoglycaemic agent, which used to lower the blood glucose levels in people with type 2 diabetes mellitus. Many analytical techniques have been used to quantify the drug in different pharmaceutical dosage forms; however, most of these methods have limited throughput in the quality control application. A disposable potentiometric microsensor responsive to metformin has recently been reported. For the first time, herein, this method of analysis has been validated according to IUPAC recommendations and successfully applied in the determination of metformin drug in some dosage form. Different drug formulations of metformin hydrochloride have been collected from the local pharmaceutical stores in Saudi Arabia and analysed using the validated microchip-based method of analysis. Subsequently, the results of this study showed that the validated method was linear, specific, precise, and accurate. The linear range was 1 × 10-1 × 10 mol L and the correlation coefficient was 0.999. The limit of detection was 2.89 × 10 mol L, and the limit of quantification was 8.77 × 10 mol L. This method demonstrated high precision, with an RSD% of less than 2.22%. The accuracy of this method was obtained by comparing the recovery percentage with percentage values less than 5%. The results obtained showed that there was no significant difference between the references, label, and recovery of less than 5%.
二甲双胍是一种口服双胍类降糖药，用于降低2型糖尿病患者的血糖水平。许多分析技术已被用于定量不同药物剂型中的该药物；然而，这些方法中的大多数在质量控制应用中的通量有限。最近报道了一种对二甲双胍有响应的一次性电位微传感器。本文首次根据国际纯粹与应用化学联合会（IUPAC）的建议对该分析方法进行了验证，并成功应用于某些剂型中二甲双胍药物的测定。从沙特阿拉伯当地药店收集了不同的盐酸二甲双胍药物制剂，并使用经过验证的基于微芯片的分析方法进行分析。随后，本研究结果表明，经过验证的方法具有线性、特异性、精密度和准确性。线性范围为1×10⁻¹×10⁻⁶mol/L，相关系数为0.999。检测限为2.89×10⁻⁷mol/L，定量限为8.77×10⁻⁷mol/L。该方法显示出高精度，相对标准偏差（RSD%）小于2.22%。通过将回收率百分比与小于5%的百分比值进行比较来获得该方法的准确度。所得结果表明，参比、标签和回收率小于5%之间没有显著差异。
