A rapid stability‐indicating reversed phase‐ultrapure liquid chromatography (RP‐UPLC) was developed and validated for the estimation of metformin (MET), linagliptin (LIN), and empagliflozin (EMP) combination in bulk and tablet dosage form using Kromasil C₁₈ column (2.1 × 50 mm, 1.8 μm) as a stationary phase and a mixture solution of 40% phosphate buffer (pH = 3) and 60% acetonitrile as mobile phase at a flow rate of 0.6 mL/min. The detection was performed at 248 nm using a photodiode array detector. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were determined. The peak area response–concentration curve was rectilinear over the range of 50–150 (MET), 5–15 (LIN), and 10–30 μg/mL (EMP) with quantitation limits of 0.042 (MET), 0.023 (LIN), and 0.059 μg/mL (EMP). The proposed method was successfully validated for the determination of MET, LIN, and EMP simultaneously in combined tablet dosage form. The performance of the proposed method was compared with reported RP‐UPLC methods and found to be rapid and economical. The developed and validated stability‐indicating RP‐UPLC method was appropriate for the quality control and drug analysis.

中文翻译：

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稳定性指示超高效液相色谱方法的开发和验证，可同时估算散装和药物剂型中的二甲双胍，利格列汀和依帕列净

开发了一种快速稳定性指示反相超液相色谱（RP-UPLC），并已使用Kromasil C ₁₈进行了散装和片剂剂型二甲双胍（MET），利格列汀（LIN）和依帕格列净（EMP）组合的评估，并经过了验证色谱柱（2.1×50 mm，1.8μm）为固定相，流速为0.6 mL / min的40％磷酸盐缓冲液（pH = 3）和60％乙腈为流动相的混合溶液。使用光电二极管阵列检测器在248nm进行检测。确定了线性，灵敏度，选择性，鲁棒性，特异性，精密度和准确性。峰面积响应-浓度曲线在50–150（MET），5–15（LIN）和10–30μg/ mL（EMP）范围内呈直线，定量限为0.042（MET），0.023（LIN）和0.059μg/ mL（EMP）。该方法已成功验证了同时测定片剂组合剂型中MET，LIN和EMP的有效性。将该方法的性能与已报道的RP-UPLC方法进行了比较，发现该方法快速，经济。