SciELO - Scientific Electronic Library Online

vol.60 número4Synthesis of Xanthene Derivatives using Template-containing Zn/MCM-41 as a Green and Reusable Catalyst; Effect of the TemplateSynthesis and Characterization of Three New di-n-butyl [bis (alkyl-aminopropionic acid)]tin (IV) índice de autoresíndice de materiabúsqueda de artículos
Home Pagelista alfabética de revistas  

Servicios Personalizados




Links relacionados

  • No hay artículos similaresSimilares en SciELO


Journal of the Mexican Chemical Society

versión impresa ISSN 1870-249X


PEREZ-CABALLERO, Guadalupe et al. Development and ICH Validation of a RP-HPLC-UV Method for the Quantification of Thimerosal in Topic Creams. J. Mex. Chem. Soc [online]. 2016, vol.60, n.4, pp.188-193. ISSN 1870-249X.

A reversed phase high-performance liquid chromatography (RP-HPLC) method for determination of Thimerosal (TMS) in topical creams was optimized and validated according to the ICH guidelines which include accuracy, precision, selectivity, robustness, limit of detection (LOD), limit of quantification (LOQ), linearity and range. For topical creams, sample treatment is often an overwhelming step essentially due to its oily nature. For the first time a simple and robust extraction procedure for TMS using phosphate buffer (pH 5.5, 0.2M) was successfully developed. This method describes the TMS quantitation by HPLC in a topical product containing 0.01% fluocinolone acetonide (FLA) as the active molecule. The HPLC separation was achieved on a Column Symmetry® and a methanol: phosphate buffer (pH 2.5, 0.05M) 70:30 v/v mobile phase and wavelength 218 nm. Results from both standards and samples showed adequate validation parameters. Noteworthy, linearity was within the range 1.2 - 2.8 µg/ mL. Additionally, robustness and TMS stability were established after sample extraction. The method provides an efficient and safe quality control tool for determination of TMS in topical creams.

Palabras llave : thimerosal; topical cream; RP-HPLC; extraction; validation.

        · resumen en Español     · texto en Inglés     · Inglés ( pdf )