The purpose of this study was to develop and validate a rapid, simple, easy, and precise high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for the simultaneous determination of canagliflozin (CGLN) and metformin (MTFN) in a combined dosage formulation. The chromatographic separation was achieved using a column type Zorbax-x Sβ-C18 (4.6 × 250 mm, 5 μm particle size). Mobile phase consisted of 0.05 M H₃PO₄, acetonitrile, and methanol in the 45:45:10 (v/v) ratio. The method was validated as per ICH guidelines in terms of system suitability, ranges, linearity, precision, specificity, accuracy, robustness, limit of quantification (LOQ) and limit of detection (LOD). The retention time (RT, t_r) for MTFN and CGLN were obtained at 8 and 9.45 min, respectively. The calibration curves were found linear in the range of 5 – 100 μg/mL for both drugs in this study, with good correlation coefficients (R² > 0.99898). The suggested design proved to be selective and stability-indicating by the resolution (R_s) of both analytes as well as by the study of forced-degradation (hydrolysis, oxidation, photolysis, and dry heat) products. The validated HPLC-DAD procedure was profitably tested for the analysis of CGLN and MTFN in their combination pharmaceutical tablet dosage form. In conclusion, a simple selective HPLC-DAD method has been successfully developed and validated for the determination of CGLN and MTFN simultaneously in pharmaceutical dosage form.

本研究的目的是开发和验证一种使用二极管阵列检测器 (DAD) 的快速、简单、容易和精确的高效液相色谱 (HPLC) 方法，用于同时测定卡格列净 (CGLN) 和二甲双胍 (MTFN)组合剂型。使用 Zorbax-x Sβ-C18 型色谱柱（4.6 × 250 mm，5 μm 粒径）实现色谱分离。流动相由 0.05 MH ₃ PO ₄、乙腈和甲醇组成，比例为 45:45:10 (v/v)。该方法按照 ICH 指南在系统适用性、范围、线性、精密度、特异性、准确度、稳健性、定量限 (LOQ) 和检测限 (LOD) 方面进行了验证。保留时间 (RT, t _r) 分别在 8 分钟和 9.45 分钟获得 MTFN 和 CGLN。发现本研究中两种药物的校准曲线在 5 – 100 μg/mL 范围内呈线性，具有良好的相关系数 ( R ² > 0.99898)。两种分析物的分辨率 ( R _s ) 以及强制降解（水解、氧化、光解和干热）产物的研究证明了所建议的设计具有选择性和稳定性。经验证的 HPLC-DAD 程序在其组合药物片剂剂型中的 CGLN 和 MTFN 分析中进行了有益的测试。总之，已成功开发并验证了一种简单的选择性 HPLC-DAD 方法，可同时测定药物剂型中的 CGLN 和 MTFN。