Publicado

2025-03-17

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

Análisis de un método experimental para la evaluación y validación de la medición de la disolución de metformina y empagliflozina en comprimidos genéricos: confirmación de los resultados mediante el método de acoplamiento

Uma análise de um método experimental para avaliação e validação da medição da dissolução de Metformina e Empagliflozina para comprimidos genéricos: Confirmação dos resultados pelo método de encaixe

DOI:

https://doi.org/10.15446/rcciquifa.v53n3.119242

Palabras clave:

Metformin, Empagliflozin, type 2 diabetes, HPLC, glycaemia control, docking simulation, molecular dynamic, drug design (en)
metformina, empagliflozina, diabetes tipo 2, HPLC, control de la glucemia, simulación de acoplamiento, dinámica molecular, diseño de fármacos (es)
metformina, empagliflozina, diabetes tipo 2, HPLC, controle da glicemia, simulação de encaixe, dinâmica molecular, design de fármacos (pt)

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Autores/as

  • Motahareh Dehghandar Department of Chemical engineering, Science and Research branch, Islamic Azad University, Tehran, Iran
  • Parisa Latifi Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
  • Sara Shahriari Department of Chemistry, Central Tehran Branch, Islamic Azad University, Tehran, Iran
  • Fatemeh Mollaamin Department of Biomedical Engineering, Faculty of Engineering and Architecture, Kastamonu University, Kastamonu, Turkey
  • Iman Eskandary Department of Chemistry, Payame Noor University, Mazandaran, Sari, Iran
  • Majid Monajjemi Departments of Chemical Engineering, Central Tehran Branch, Islamic Azad University, Tehran, Iran

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.

Objetivo: Validación del ensayo y disolución de metformina y empagliflozina en comprimidos de 500:5 mg para evaluar la eficacia y seguridad de la linagliptina frente a placebo en pacientes con diabetes tipo 2. Materiales y métodos: El sistema HPLC utilizado fue Shimadzu LC-2010 HT con detector UV y para la solución madre estándar de empagliflozina 1: se prepararon con precisión 28 mg de empagliflozina. Se inyectaron por separado 10 μL de solución estándar y la solución de muestra en el sistema cromatográfico. Los pacientes con un control inadecuado de la glucemia a pesar de la administración de metformina en dosis estables recibieron empagliflozina de etiqueta abierta como terapia complementaria durante varias semanas. Todos los pacientes continuaron el tratamiento con metformina y empagliflozina o metformina y empagliflozina. El criterio de valoración principal fue el cambio con respecto al valor inicial. Resultados: Los experimentos mostraron una reducción significativa del problema en pacientes con diabetes tipo 2. Además, los resultados del método de acoplamiento confirmaron también la eficacia de los comprimidos de metformina/empagliflozina para controlar mejor la enfermedad diabética tipo 2. Conclusiones: La empagliflozina en combinación con metformina/empagliflozina durante 24 semanas mejoró el control de la glucemia y fue bien tolerada.

Objetivo: Validação para ensaio e dissolução de metformina e Empagliflozina em comprimido 500:5 mg para avaliar a eficácia e segurança da linagliptina vs. placebo em pacientes com diabetes tipo 2. Materiais e métodos: O sistema HPLC usado foi Shimadzu LC-2010 HT com detector UV e estoque padrão de Empagliflozina 1: 28 mg de Empagliflozina foram preparados com precisão. Separadamente, 10 μL de solução padrão e solução de amostra foram injetados no sistema cromatográfico. Pacientes com controle glicêmico inadequado, apesar da metformina em dose estável, receberam Empagliflozina de rótulo aberto como terapia complementar por várias semanas. Todos os pacientes continuaram o tratamento com metformina e Empagliflozina ou metformina e Empagliflozina. O desfecho primário foi a mudança da linha de base. Resultados: Os experimentos exibiram significativamente uma redução do problema em pacientes com diabetes tipo 2. Além disso, os resultados do método de encaixe confirmaram também a eficácia dos comprimidos de Metformina/Empagliflozina para melhor controle da doença diabética tipo 2. Conclusões: A empagliflozina em Metformina/Empagliflozina por 24 semanas melhorou o controle da glicemia e foi bem tolerada.

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Cómo citar

APA

Dehghandar, M., Latifi, P., Shahriari, S., Mollaamin, F., Eskandary, I. y Monajjemi, M. (2025). 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. Revista Colombiana de Ciencias Químico-Farmacéuticas, 53(3), 905–929. https://doi.org/10.15446/rcciquifa.v53n3.119242

ACM

[1]
Dehghandar, M., Latifi, P., Shahriari, S., Mollaamin, F., Eskandary, I. y Monajjemi, M. 2025. 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. Revista Colombiana de Ciencias Químico-Farmacéuticas. 53, 3 (mar. 2025), 905–929. DOI:https://doi.org/10.15446/rcciquifa.v53n3.119242.

ACS

(1)
Dehghandar, M.; Latifi, P.; Shahriari, S.; Mollaamin, F.; Eskandary, I.; Monajjemi, M. 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. Rev. Colomb. Cienc. Quím. Farm. 2025, 53, 905-929.

ABNT

DEHGHANDAR, M.; LATIFI, P.; SHAHRIARI, S.; MOLLAAMIN, F.; ESKANDARY, I.; MONAJJEMI, M. 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. Revista Colombiana de Ciencias Químico-Farmacéuticas, [S. l.], v. 53, n. 3, p. 905–929, 2025. DOI: 10.15446/rcciquifa.v53n3.119242. Disponível em: https://revistas.unal.edu.co/index.php/rccquifa/article/view/119242. Acesso em: 29 mar. 2025.

Chicago

Dehghandar, Motahareh, Parisa Latifi, Sara Shahriari, Fatemeh Mollaamin, Iman Eskandary, y Majid Monajjemi. 2025. «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». Revista Colombiana De Ciencias Químico-Farmacéuticas 53 (3):905-29. https://doi.org/10.15446/rcciquifa.v53n3.119242.

Harvard

Dehghandar, M., Latifi, P., Shahriari, S., Mollaamin, F., Eskandary, I. y Monajjemi, M. (2025) «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», Revista Colombiana de Ciencias Químico-Farmacéuticas, 53(3), pp. 905–929. doi: 10.15446/rcciquifa.v53n3.119242.

IEEE

[1]
M. Dehghandar, P. Latifi, S. Shahriari, F. Mollaamin, I. Eskandary, y M. Monajjemi, «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», Rev. Colomb. Cienc. Quím. Farm., vol. 53, n.º 3, pp. 905–929, mar. 2025.

MLA

Dehghandar, M., P. Latifi, S. Shahriari, F. Mollaamin, I. Eskandary, y M. Monajjemi. «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». Revista Colombiana de Ciencias Químico-Farmacéuticas, vol. 53, n.º 3, marzo de 2025, pp. 905-29, doi:10.15446/rcciquifa.v53n3.119242.

Turabian

Dehghandar, Motahareh, Parisa Latifi, Sara Shahriari, Fatemeh Mollaamin, Iman Eskandary, y Majid Monajjemi. «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». Revista Colombiana de Ciencias Químico-Farmacéuticas 53, no. 3 (marzo 17, 2025): 905–929. Accedido marzo 29, 2025. https://revistas.unal.edu.co/index.php/rccquifa/article/view/119242.

Vancouver

1.
Dehghandar M, Latifi P, Shahriari S, Mollaamin F, Eskandary I, Monajjemi M. 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. Rev. Colomb. Cienc. Quím. Farm. [Internet]. 17 de marzo de 2025 [citado 29 de marzo de 2025];53(3):905-29. Disponible en: https://revistas.unal.edu.co/index.php/rccquifa/article/view/119242

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