Development and ICH Validation of a RP-HPLC-UV Method for the Quantification of Thimerosal in Topic Creams

Authors

  • Guadalupe Pérez-Caballero Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México
  • Nancy Muro-Hidalgo Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México
  • Elvia Adriana Morales-Hipólito Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México
  • Alma Villaseñor Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México
  • Raquel López-Arellano Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

DOI:

https://doi.org/10.29356/jmcs.v60i4.110

Keywords:

thimerosal, topical cream, RP-HPLC, extraction, validation

Abstract

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.

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Author Biographies

Guadalupe Pérez-Caballero, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

Unidad de Investigación Multidisciplinaria (UIM)

Nancy Muro-Hidalgo, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

Unidad de Investigación Multidisciplinaria (UIM)

Elvia Adriana Morales-Hipólito, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

Unidad de Investigación Multidisciplinaria (UIM)

Alma Villaseñor, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

Unidad de Investigación Multidisciplinaria (UIM)

Raquel López-Arellano, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México

Unidad de Investigación Multidisciplinaria (UIM)

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Published

2017-10-12

Issue

Section

Regular Articles

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