An analytical of an experimental method for evaluation and validation from measuring dissolution of Metformin and Empagliflozin for generic tablets: Confirmation the results by docking method
Abstract
Aim: Validation for assay and dissolution of metformin and Empagliflozin in tablet 500:5 mg for evaluating the efficacy and safety of linagliptin vs. placebo in patients with type 2 diabetes. Materials and methods: The HPLC system used was Shimadzu LC-2010 HT with UV detector and Empagliflozin standard stock 1: 28 mg of Empagliflozin was accurately prepared. Separately 10 μL of standard solution and sample solution was injected into the chromatographic system. Patients with inadequate glycaemia control despite stable-dose metformin received open-label Empagliflozin as add-on therapy for several weeks. All patients continued treatment with metformin and Empagliflozin or metformin and Empagliflozin. The primary endpoint was change from baseline. Results: The experiments were significantly exhibited a reducing the problem in patients with type 2 diabetes. In addition, results of docking method confirmed also the effectiveness of Metformin/ Empagliflozin tablets to better controlling of diabete-type-2 disease. Conclusions: Empagliflozin in Metformin/Empagliflozin for 24 weeks improved glycaemia control and was well tolerated.
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