Abstract
BackgroundIn 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.ResultsMetformin 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.ConclusionThe 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.
Highlights
In the present study, an improved simple, specific, rapid, sensitive, precise, accurate and stabilityindicating RP-HPLC method for the simultaneous estimation of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets was developed and validated
Globally, about 463 million people are suffering from type-2 diabetes mellitus [1] which is manifested by polydipsia, polyuria, and polyphagia and requires a lifetime treatment with antidiabetic drugs [2]
Reference standard of ertugliflozin pidolate was obtained as gift sample from Ajanta Pharma, Mumbai and metformin HCl from Laurus Labs, Hyderabad
Summary
An improved simple, specific, rapid, sensitive, precise, accurate and stabilityindicating RP-HPLC method for the simultaneous estimation of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets was developed and validated. About 463 million people are suffering from type-2 diabetes mellitus [1] which is manifested by polydipsia, polyuria, and polyphagia and requires a lifetime treatment with antidiabetic drugs [2]. The treatment goals involve the achievement of glycemic control and reducing the diabetes-associated cardiovascular risk. The risk of hypoglycemia is insignificant with metformin and drug interactions are less making it a highly safe and acceptable first-line of drug for the treatment of early type-2 diabetes mellitus [3]. The pathogenesis of type-2 diabetes mellitus is multiplex, involving several organs, and treatments using a combination of drugs with different mechanisms of action effectively controls the plasma glucose levels [4].
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