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

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 de...

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Bibliographic Details
Published in:Journal of separation science 2016-07, Vol.39 (14), p.2689-2701
Main Authors: Oliva, Alexis, Monzón, Cecilia, Santoveña, Ana, Fariña, José B., Llabrés, Matías
Format: Article
Language:English
Subjects:
Chromatography
Chromatography, High Pressure Liquid
Computer programs
Computer simulation
Content uniformity
Design analysis
Design of experiments
Design space
Error analysis
High performance liquid chromatography
Hydrogels
Hydrogels - chemistry
Mathematical analysis
Monte Carlo Method
Monte Carlo simulation
Strategy
Triamcinolone
Triamcinolone Acetonide - analysis
Ultra high performance liquid chromatography
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Summary: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.
ISSN:1615-9306
1615-9314
DOI:10.1002/jssc.201600273