In the present study, an improved simple, specific, rapid, sensitive, precise, accurate and stability-indicating RP-HPLC method for the simultaneous estimation of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets was developed and validated. The separation of ertugliflozin pidolate and metformin HCl was achieved isocratically on Kromasil C18 column (150 mm × 4.6 mm, 5 μm) using 0.1% ortho-phosphoric acid buffer (pH 2.7):acetonitrile (65:35% v/v) as mobile phase, pumped at a flow rate of 1 ml/min and column temperature of 30 ± 2 °C. HPLC grade water:ACN (1:1) was used as diluent. About 10 μl of standard solution of the drugs was injected, and the eluted analytes were detected at 224 nm. Metformin HCl was eluted at 2.170 min and ertugliflozin pidolate at 2.929 min with a run time of 5.0 min. Linearity of the developed method was observed in the concentration range of 0.9375–5.625 μg/ml for ertugliflozin pidolate and 62.5–375 μg/ml for metformin HCl with a correlation coefficient of 0.999 for both the drugs. LOD for ertugliflozin pidolate and metformin HCl were 0.025 μg/ml and 0.87 μg/ml respectively. LOQ for ertugliflozin pidolate and metformin HCl were 0.076 μg/ml and 2.63 μg/ml. The developed RP-HPLC method for the simultaneous estimation of ertugliflozin pidolate and metformin HCl in bulk and tablets was simple, rapid, sensitive, accurate, precise, linear, and stability indicating. Hence, the developed method could be used for the routine quality control of the drugs in bulk and tablets.

中文翻译：

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稳定指示性RP-HPLC法同时测定散装和片剂中盐酸度尔格列净和盐酸二甲双胍的建立与验证

在本研究中，开发并验证了一种改进的简单，特异，快速，灵敏，精确，准确和稳定的指示性RP-HPLC方法，用于同时估算散装和片剂中的ertugliflozin pidolate和metformin hydrochloride。使用0.1％的正磷酸缓冲液（pH 2.7）：乙腈（65：35％v / v）作为流动相，在Kromasil C18色谱柱（150 mm×4.6 mm，5μm）上等度分离了ertugliflozin pidolate和HCl二甲双胍。相，以1 ml / min的流速泵送，柱温为30±2°C。HPLC级水：ACN（1：1）用作稀释剂。注射约10μl的药物标准溶液，并在224 nm处检测到洗脱的分析物。盐酸二甲双胍在2.170分钟处洗脱，而ertugliflozin pidolate在2.929分钟处洗脱，运行时间为5.0分钟。所开发方法的线性在ertugliflozin pidolate的浓度范围为0.9375-5.625μg/ ml和对于盐酸二甲双胍为62.5-375μg/ ml的范围内，两种药物的相关系数均为0.999。吡格列净磷酸酯和盐酸二甲双胍的LOD分别为0.025μg/ ml和0.87μg/ ml。吡格列净酯和盐酸二甲双胍的最低定量限为0.076μg/ ml和2.63μg/ ml。所开发的同时测定散装和片剂中依托格列净磷酸酯和盐酸二甲双胍的RP-HPLC方法简便，快速，灵敏，准确，精确，线性和稳定性高。因此，所开发的方法可用于散装和片剂药物的常规质量控制。盐酸二甲双胍为5-375μg/ ml，两种药物的相关系数均为0.999。吡格列净磷酸酯和盐酸二甲双胍的LOD分别为0.025μg/ ml和0.87μg/ ml。吡格列净酯和盐酸二甲双胍的LOQ分别为0.076μg/ ml和2.63μg/ ml。所开发的同时测定散装和片剂中依托格列净磷酸酯和盐酸二甲双胍的RP-HPLC方法简便，快速，灵敏，准确，精确，线性和稳定性高。因此，所开发的方法可用于散装和片剂药物的常规质量控制。盐酸二甲双胍为5-375μg/ ml，两种药物的相关系数均为0.999。吡格列净磷酸酯和盐酸二甲双胍的LOD分别为0.025μg/ ml和0.87μg/ ml。吡格列净酯和盐酸二甲双胍的最低定量限为0.076μg/ ml和2.63μg/ ml。所开发的同时测定散装和片剂中依托格列净磷酸酯和盐酸二甲双胍的RP-HPLC方法简便，快速，灵敏，准确，精确，线性和稳定性高。因此，所开发的方法可用于散装和片剂药物的常规质量控制。所开发的同时测定散装和片剂中依托格列净磷酸酯和盐酸二甲双胍的RP-HPLC方法简便，快速，灵敏，准确，精确，线性和稳定性高。因此，所开发的方法可用于散装和片剂药物的常规质量控制。所开发的同时测定散装和片剂中依托格列净磷酸酯和盐酸二甲双胍的RP-HPLC方法简便，快速，灵敏，准确，精确，线性和稳定性高。因此，所开发的方法可用于散装和片剂药物的常规质量控制。