Extensive literature review revealed that no RP–LC method has been developed for simultaneous estimation of EMPA, LINA and MET in combined dosage form. This is a newer combination approved by USFDA on 4th June 2019 and it is launch in the United State Market on 27th January 2020. A simple, sensitive, specific, precise and accurate reverse phase—high performance liquid chromatography (RP- HPLC) method has been developed for simultaneous estimation of Empagliflozin, Linagliptin and Metformin HCl in bulk and synthetic mixture. Phenomenex C18 column (250 mm × 4.6 mm, 5 µm) was used as stationary phase for chromatographic separation through isocratic elution using Acetonitrile: Methanol: Water in a ratio (27: 20: 53, v/v/v) pH 4 adjusted with 1% Ortho-phosphoric acid as mobile phase at flow rate 1 ml/min. PDA detector was used for simultaneous analysis of all three drugs at common wavelength 223 nm and the each injection volume was 20 µl. The linearity range for Empagliflozin, Linagliptin and Metformin HCl was found to be 0.5–5 µg/ml, 0.25–2.5 µg/ml, and 50–500 µg/ml, respectively. The retention time for Empagliflozin, Linagliptin and Metformin HCl was found to be 14.5 min, 3.4 min and 2.01 min, respectively. The percentage (%) recovery was found to be 99.98–100.81% for Empagliflozin, 99.33–100.57% for Linagliptin and 100.65–101.35% for Metformin HCl respectively. As per the international Conference on Harmonisation (ICH) Q2 (R1) guideline, proposed RP–LC method validation has been carried out. The proposed RP–LC method was repeatable and selective as per statistical analysis and it can be use for simultaneous estimation of Empagliflozin, Linagliptin and Metformin HCl in bulk and synthetic mixture. The proposed method might be applied for simultaneous estimation of all three drugs in pharmaceutical formulation.

中文翻译：

---

使用 RP-LC 方法同时定量散装和合成混合物中的恩格列净、利格列汀和盐酸二甲双胍

大量文献回顾表明，尚未开发出 RP-LC 方法来同时估算组合剂型中的 EMPA、LINA 和 MET。这是一种较新的组合，于 2019 年 6 月 4 日获得美国食品药品监督管理局批准，并于 2020 年 1 月 27 日在美国市场上市。开发用于同时估算散装和合成混合物中的恩格列净、利格列汀和盐酸二甲双胍。Phenomenex C18 柱（250 mm × 4.6 mm，5 µm）用作固定相，通过等度洗脱使用乙腈：甲醇：水按比例（27：20：53，v/v/v）调节 pH 4，进行色谱分离1% 正磷酸作为流动相，流速为 1 ml/min。PDA 检测器用于在共同波长 223 nm 下同时分析所有三种药物，每次进样量为 20 µl。恩格列净、利格列汀和盐酸二甲双胍的线性范围分别为 0.5–5 µg/ml、0.25–2.5 µg/ml 和 50–500 µg/ml。恩格列净、利格列汀和盐酸二甲双胍的保留时间分别为 14.5 分钟、3.4 分钟和 2.01 分钟。发现恩格列净的回收率 (%) 分别为 99.98–100.81%、利格列汀的 99.33–100.57% 和盐酸二甲双胍的 100.65–101.35%。根据国际协调会议 (ICH) Q2 (R1) 指南，已执行提议的 RP-LC 方法验证。根据统计分析，提出的 RP-LC 方法具有可重复性和选择性，可用于同时估计 Empagliflozin，利格列汀和盐酸二甲双胍散装和合成混合物。所提出的方法可用于同时估计药物制剂中的所有三种药物。