The antidiabetic drugs metformin, gliclazide and glipizide have been widely used and studied in terms of pharmacological and antidiabetic effects, and their individual stability has been studied in the literature. However, the drugs’ combined stability profiling remains poorly understood, and hence the aim of this study was to investigate the collective stability profiling of different combinations at various controlled conditions. Degradation assessments were carried out on metformin, glipizide and gliclazide by applying a stability-indicating HPLC method that was developed and validated in accordance with ICH guidelines. Glipizide, gliclazide, metformin and the binary mixtures (metformin/glipizide and metformin/gliclazide) were subjected to different forced degradation conditions and were detected at 227 nm by an isocratic separation on an Alltima CN column (250 mm × 4.6 mm × 5µ) utilizing a mobile phase that consists of 20 mM ammonium formate buffer (pH 3.5) and acetonitrile at a ratio of (45:55, v/v). The method is linear (R² = 0.9999) at the concentration range 2.5–150 µg/ml for metformin and 1.25–150 µg/ml for sulfonylureas respectively and offers a specific and sensitive tool for their determination in <10 min chromatographic run. All drug peaks were sharp and well separated. Stress degradation revealed that metformin has a remarkable sensitivity to alkaline stress, glipizide was more sensitive to thermal degradation while gliclazide exhibited almost full degradation in acidic, alkaline and oxidative stress conditions.

抗糖尿病药物二甲双胍，格列齐特和格列吡嗪在药理作用和抗糖尿病作用方面已得到广泛使用和研究，其个体稳定性已在文献中得到研究。然而，对药物的联合稳定性分析仍然知之甚少，因此，本研究的目的是研究在各种受控条件下不同组合的集体稳定性分析。通过应用根据ICH指南开发和验证的稳定性指示HPLC方法，对二甲双胍，格列吡嗪和格列齐特进行了降解评估。格列吡嗪，格列齐特，将二甲双胍和二元混合物（二甲双胍/格列吡嗪和二甲双胍/格列齐特）置于不同的强制降解条件下，并在Alltima CN色谱柱（250 mm×4.6 mm×5µ）上通过等度分离在227 nm下检测，并采用流动相由比例为（45:55，v / v）的20 mM甲酸铵缓冲液（pH 3.5）和乙腈组成。该方法是线性的（R²  = 0.9999），二甲双胍的浓度范围为2.5–150 µg / ml，磺酰脲的浓度范围为1.25–150 µg / ml，这为在<10分钟的色谱运行中进行测定提供了一种特异性和灵敏的工具。所有药物峰均清晰且分离良好。应力降解显示二甲双胍对碱性应力具有显着的敏感性，格列吡嗪对热降解更敏感，而格列齐特在酸性，碱性和氧化应激条件下几乎完全降解。