A sensitive, simple and validated thin-layer chromatography (TLC) method (method A) and a high-performance thin-layer chromatography (HPTLC) method (method B) have been developed for the simultaneous determination of linagliptin (LNG) and empagliflozin (EMP) in laboratory prepared mixtures and in their co-formulated pharmaceutical preparations. Chromatographic separation has been done using TLC silica gel 60 F₂₅₄ aluminum plates (20 cm × 10 cm, 0.25 mm thickness) and the mobile phase consisting of chloroform‒methanol‒ammonia (33%) (9:1:0.1, V/V) for method A. Chromatographic separation in method B was carried out using HPTLC nano-silica gel 60 F₂₅₄ glass plates (10 cm × 10 cm, 0.1 mm thickness) and the mobile phase consisting of chloroform‒methanol‒ammonia (25%) (10:1:0.1, V/V). The optimized chromatographic conditions gave good peak shapes with good resolutions at acceptable R_F values of 0.25 ± 0.01 for EMP, 0.56 ± 0.01 for LNG in method A, 0.31 ± 0.01 for EMP and 0.71 ± 0.01 for LNG in method B. Both methods were validated for linearity, accuracy, precision and specificity. The calibration plots were linear over a concentration range of 0.4‒10 µg/band with a correlation coefficient of 0.9998 for EMP and 0.2‒5.0 µg/band with a correlation coefficient of 0.9998 for LNG in method A. In method B, the linear range for calibration was 0.1‒5.0 µg/band with a correlation coefficient of 0.9999 for EMP and 0.05‒2.5 µg/band with a correlation coefficient of 0.9999 for LNG. The optimized methods were successfully applied for the determination of the studied drugs in laboratory prepared mixtures and in their co-formulated pharmaceutical preparations with no significant difference observed upon statistical comparison between the proposed and reported methods.

已开发出一种灵敏，简单且经过验证的薄层色谱（TLC）方法（方法A）和高性能薄层色谱（HPTLC）方法（方法B），用于同时测定利格列汀（LNG）和依帕格列净（ EMP）在实验室制备的混合物及其共同配制的药物制剂中。使用TLC硅胶60 F ₂₅₄铝板（20 cm×10 cm，0.25 mm厚度）和由氯仿‒甲醇‒氨水（33％）（9：1：0.1，V / V）组成的流动相进行色谱分离）方法B.方法B的色谱分离是使用HPTLC纳米硅胶60 F _254进行的玻璃板（10厘米×10厘米，厚度0.1毫米），流动相由氯仿‒甲醇‒氨水（25％）（10：1：0.1，V / V）组成。优化的色谱条件在可接受的R _F下给出了良好的峰形和良好的分离度方法A的EMP值0.25±0.01，方法A的LNG值0.56±0.01，方法B的EMP值0.31±0.01和方法LNG 0.71±0.01。两种方法的线性，准确性，精密度和特异性均得到验证。在方法A中，校准图在0.4‒10 µg /带的浓度范围内是线性的，对于EMP的相关系数为0.9998，在LNG浓度为0.2‒5.0 µg /带的范围内，对于LNG的相关系数为0.9998。 EMP的校正系数为0.1±5.0 µg /条带，LNG的校正系数为0.05±2.5 µg /条带，相关系数0.9999。