A simple, selective, precise, rapid and accurate stability-indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for the estimation of dapagliflozin and metformin in tablet dosage form. In this work, methanol–ethyl acetate–ammonium acetate (6:4:0.1, V/V) as the mobile phase and aluminum-backed TLC plates pre-coated with 250 µm layer of silica gel 60F₂₅₄ as the stationary phase were used for the estimation of dapagliflozin and metformin. The wavelength selected for detection was 220 nm. The linearity range was found to be 20–100 ng/spot (r² = 0.9985) for dapagliflozin and 500–2500 ng/spot (r² = 0.9984) for metformin. Validation of the developed method was performed as per the International Council for Harmonisation (ICH) guidelines. Stress testing of dapagliflozin and metformin was performed under acidic, alkaline, oxidative, photolytic and dry-heat degradation conditions. The chromatographic conditions successfully resolved dapagliflozin and metformin from their degradation products, formed under various stress conditions. From stress testing, dapagliflozin was found to be significantly degrading under acidic, alkaline, oxidative, photolytic and dry-heat degradation conditions, while metformin was found to be significantly degrading in acidic and alkaline degradation conditions and stable under oxidative, photolytic and dry-heat degradation conditions. Tablet dosage form of dapagliflozin and metformin was analyzed by the developed method.

开发并验证了一种简单、选择性、精确、快速和准确的稳定性指示高效薄层色谱 (HPTLC) 方法，用于评估片剂剂型中的达格列净和二甲双胍。在这项工作中，甲醇-乙酸乙酯-乙酸铵 (6:4:0.1, V/V ) 作为流动相和铝背 TLC 板预涂有 250 µm 硅胶层 60F ₂₅₄作为固定相用于估计达格列净和二甲双胍。选择用于检测的波长为 220 nm。发现 达格列净的线性范围为 20–100 ng/点 ( r ² = 0.9985) 和 500–2500 ng/点 ( r ² = 0.9984) 对于二甲双胍。根据国际协调委员会 (ICH) 指南对开发的方法进行了验证。达格列净和二甲双胍的压力测试在酸性、碱性、氧化、光解和干热降解条件下进行。色谱条件成功地将达格列净和二甲双胍从它们在各种压力条件下形成的降解产物中分离出来。从压力测试中，发现达格列净在酸性、碱性、氧化、光解和干热降解条件下显着降解，而二甲双胍在酸性和碱性降解条件下显着降解，在氧化、光解和干热条件下稳定降解条件。