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Estabilidad fisicoquímica de tres marcas genéricas de metformina en solución.
- Source :
-
Acta Pediatrica de Mexico . mar/abr2014, Vol. 35 Issue 2, p104-110. 7p. 2 Charts. - Publication Year :
- 2014
-
Abstract
- Pharmacological management of insulin resistance and dyslipidaemias in children and adolescents is required to prevent the development of metabolic syndrome (MS) and type II diabetes mellitus (DM2). Material and method: we developed extemporaneous formulations from 500 mg-tablets from three generic brands, commercially available in Mexican drugstores: Medimart™, Farmacias del Ahorro™ and Primer NivelTM, dissolved in water sweetened with Splenda, which made them palatable and allowed customised dose adjustment. Solutions were stored at four environmental conditions: 25°C exposed to light, 25°C protected from light, 4°C and 40°C, and their physicochemical stability was assayed. The stability of the drug was determined by ultra performance liquid chromatography and ultraviolet detection (UPLC-UV) and by measuring the pH of the stock solution. The mobile phase consisted of (KH2PO4) 0.1 M, pH = 6.5, 4.6 mM sodium dodecyl sulphate (SDS) and acetonitrile (63:7:30) at 0.8 mL/min, column VARIAN Pursuit C8 150 x 3.9 mm tempered at 40°C, with detection at 236 nm. Results: Metformin from all trademarks was stable at all storage conditions for up to 30 days, retaining more than 90% of the initial amount of active drug, with a pH of 7.4 ± 0.3. Conclusion: Metformin extemporaneous formulations may be developed from either the innovator or generic brands, having the advantage of saving money and conserving the stability of its physicochemical properties. [ABSTRACT FROM AUTHOR]
Details
- Language :
- Spanish
- ISSN :
- 01862391
- Volume :
- 35
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- Acta Pediatrica de Mexico
- Publication Type :
- Academic Journal
- Accession number :
- 95882745