A sensitive, accurate, precise, and robust high-performance thin-layer chromatography (HPTLC) method has been developed for the simultaneous quantification of empagliflozin, linagliptin, and metformin HCl in bulk and synthetic mixture. The method applied HPTLC aluminum plates pre-coated with silica gel 60 F₂₅₄ as the stationary phase along with n-butanol:water:glacial acetic acid (6:3:1, v/v) as the mobile phase. The Rf values of empagliflozin, linagliptin, and metformin HCl were found to be 0.73, 0.52, and 0.33, respectively. Densitometric analysis was carried out in the absorbance mode at 223 nm. The method was obtained linear in the range of 0.1–0.7 μg/band for empagliflozin, 0.05–0.35 μg/band for linagliptin, and 10–70 μg/band for metformin HCl, respectively. From synthetic mixture, the percentage (%) amounts of all three drugs were found to be more than 98% by the proposed HPTLC method. The method was validated as per the International Conference on Harmonisation (ICH) guideline Q2(R1).

中文翻译：

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恩帕格列净，利格列汀和盐酸二甲双胍联合治疗的光密度同时估算

已经开发了一种灵敏，准确，精确和可靠的高性能薄层色谱（HPTLC）方法，用于同时定量大批量和合成混合物中的依帕列净，利拉列汀和盐酸二甲双胍。该方法使用预涂有硅胶60 F ₂₅₄作为固定相的HPTLC铝板以及正丁醇：水：冰醋酸（6：3：1，v / v）作为流动相。恩帕格列净，利格列汀和盐酸二甲双胍的Rf值分别为0.73、0.52和0.33。在223nm的吸光度模式下进行光密度分析。恩帕格列净的线性范围为0.1–0.7μg/带，利格列汀的线性范围为0.05–0.35μg/带，盐酸二甲双胍的线性范围为10–70μg/带。从合成混合物中，通过提出的HPTLC方法发现所有三种药物的百分比（％）量均超过98％。该方法已根据国际协调会议（ICH）指南Q2（R1）进行了验证。