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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

RODRIGUEZ HERNANDEZ, Yaslenis; SUAREZ PEREZ, Yania  y  IZQUIERDO CASTRO, Adalberto. Validation of ascorbic acid tablets of national production by high-performance liquid chromatography method. Rev Cubana Farm [online]. 2009, vol.43, n.3. ISSN 0034-7515.

We validate an analytical method by high-performance liquid chromatography to determine ascorbic acid proportion in vitamin C tablets, which was designed as an alternative method to quality control and to follow-up of active principle chemical stability, since official techniques to quality control of ascorbic acid in tablets are not selective with degradation products. Method was modified according to that reported in USP 28, 2005 for analysis of injectable product. We used a RP-18 column of 250 x 4.6 mm 5 mm with a UV detector to 245 nm. Its validation was necessary for both objectives, considering parameters required for methods of I and II categories. This method was enough linear, exact, and precise in the rank of 100-300 mg/mL. Also, it was selective with remaining components of matrix and with the possible degradation products achieved in stressing conditions. Detection and quantification limits were estimated. When method was validated it was applied to ascorbic acid quantification in two batches of expired tablets and we detected a marked influence of container in active degradation principle after 12 months at room temperature.

Palabras clave : Ascorbic acid; high-performance liquid chromatography; quality control; stability studies; validation; vitamin C tablets.

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