title: Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index.
abstract: An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the design of experiments/design space strategy was used. For this, the free R-program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre-study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty.
authors.affiliation: Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Ciencias de la Salud-Sección Farmacia, Universidad de La Laguna, Tenerife, Spain.
authors.forename: Alexis
authors.initials: A
authors.lastname: Oliva
authors.affiliation: Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Ciencias de la Salud-Sección Farmacia, Universidad de La Laguna, Tenerife, Spain.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Monzón
authors.affiliation: Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Ciencias de la Salud-Sección Farmacia, Universidad de La Laguna, Tenerife, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Santoveña
authors.affiliation: Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Ciencias de la Salud-Sección Farmacia, Universidad de La Laguna, Tenerife, Spain.
authors.forename: José B
authors.initials: JB
authors.lastname: Fariña
authors.affiliation: Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Ciencias de la Salud-Sección Farmacia, Universidad de La Laguna, Tenerife, Spain.
authors.forename: Matías
authors.initials: M
authors.lastname: Llabrés
mesh_terms: D002851:Chromatography, High Pressure Liquid; D020100:Hydrogels / Q000737:chemistry*; D009010:Monte Carlo Method; D014222:Triamcinolone Acetonide / Q000032:analysis*
chemical_list: D020100:Hydrogels; D014222:Triamcinolone Acetonide
keywords: Content uniformity; Design of experiments; Design space; Triamcinolone; Ultra high performance liquid chromatography