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Journal of the Chilean Chemical Society
versión On-line ISSN 0717-9707
DE DIEGO, M et al. STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD. J. Chil. Chem. Soc. [online]. 2010, vol.55, n.4, pp.450-453. ISSN 0717-9707. http://dx.doi.org/10.4067/S0717-97072010000400008.
Ramipril is an angiotensin-converting enzyme inhibitor which has chemical structure susceptible to degradation, therefore in this work forced degradation studies of ramipril were carried out by a developed and validated stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under hydrolysis (0.1 N HCl, water and 0.1 N NaOH), oxidation (3% H2O2), heat (70°C) and photolysis (UV and VIS radiation). The drug was degraded under acidic, neutral, alkaline, oxidation and thermal stress conditions but it was stable under photolysis. Chromatographic separation of ramipril from its degradation products was achieved on a RP-18 column, using a mobile phase consisting of methanol - tetrahydrofuran - phosphate buffer (pH 2.4; 0.01M) (55:5:40, v/v/v) at a flow rate of 1.0 mL min-1 and UV detection at 215 nm. The assay was linear for ramipril concentrations of 50-300 ug/mL. The developed method was stability indicating, specific, accurate and precise for ramipril determination. This method was used to quantify ramipril in tablets. The results showed that the method described here is suitable for quantitative determination and the stability study of ramipril.
Palabras clave : Stress testing; stability-indicating; ramipril; drug substance; tablets.