A QBD With Design-of-Experiments Approach for Development of a State-of-the-Art Uplc Purity Method for Carbamazepine

Schmidt, Alexander H.; Wess, Carsten

doi:10.1080/10826076.2013.853312

Cited by 14 publications

(17 citation statements)

References 7 publications

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“…Traditionally, optimization in analytical chemistry has been carried out by monitoring the influence of one factor at a time on an experimental response. While only one parameter is changed, others are kept at a constant level . This optimization technique is called one‐variable‐at‐a‐time (OVAT).…”

Section: Resultsmentioning

confidence: 99%

“…DoE overcomes the limitations of OVAT due to systematic arrangement and predicts the optimal points through regression models. However, one of the main problems is to select the experimental design because not all statistical designs have the same ability to identify which factors are important and to quantify the effect of each variable . The Plackett and Burman, Box–Behnken, Doehlert, principal component analysis, or central composite designs are some widely used examples .…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2016

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2016

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“…In order to simulate the appropriate conditions for the air‐spray deposition, a design of experiments (DoE) was carried out. A DoE is a statistical methodology for the planning and analysis of an experiment and allows to identify and quantify the causes of an effect in the experiment . By means of the DoE, it is possible to determine the variables and their interactions that significantly affect the experiment (Pareto diagram).…”

Section: Methodsmentioning

confidence: 99%

“…A DoE is a statistical methodology for the planning and analysis of an experiment and allows to identify and quantify the causes of an effect in the experiment. 26,27 By means of the DoE, it is possible to determine the variables and their interactions that significantly affect the experiment (Pareto diagram). This requires setting a response variable, which will be analyzed, and vary the other ones defining a maximum and minimum for each.…”

Section: (3) Characterizationmentioning

confidence: 99%

Effective Air‐Spray Deposition of Thin Films Obtained by Sol–Gel Process onto Complex Pieces of Sanitary Ware

Enríquez

Rubia

González³

et al. 2015

J. Am. Ceram. Soc.

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A deposition mechanism by air‐spray technique is carried out for depositing silica‐based thin films obtained by the sol–gel process. The air‐spray deposition is very useful to coat large and complex surfaces with different morphologies and roughnesses which favors the technology scale‐up, contrary to the most used deposition methods in the sol–gel process (dip and spin coating). To establish the adequate conditions of these techniques, a complete study of the sol properties (rheology, FT‐IR, roughness, thickness) is attempted, which has allowed determining the parameters for the effective air‐spray deposition of homogeneous thin films. By means of an experimental design, it has been possible to validate the selected parameters. Finally, a scheme of an effective spray deposition model is proposed for a better understanding of the deposition mechanisms.

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“…For this, the concept of the analytical target profile (ATP) was used to describe how variability in method performance parameters can affect the result quality. The ATP defines method performance requirements, and the probability statement to control the risk of making incorrect decisions from results . Any method conforming to the ATP criteria is considered suitable .…”

Section: Introductionmentioning

confidence: 99%

Application of capability indices and control charts in the analytical method control strategy

Oliva

Martínez

2017

J of Separation Science

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In this study, we assessed the usefulness of control charts in combination with the process capability indices, C and C , in the control strategy of an analytical method. The traditional X-chart and moving range chart were used to monitor the analytical method over a 2-year period. The results confirmed that the analytical method is in-control and stable. Different criteria were used to establish the specifications limits (i.e. analyst requirements) for fixed method performance (i.e. method requirements). If the specification limits and control limits are equal in breadth, the method can be considered "capable" (C = 1), but it does not satisfy the minimum method capability requirements proposed by Pearn and Shu (2003). Similar results were obtained using the C index. The method capability was also assessed as a function of method performance for fixed analyst requirements. The results indicate that the method does not meet the requirements of the analytical target approach. A real-example data of a SEC with light-scattering detection method was used as a model whereas previously published data were used to illustrate the applicability of the proposed approach.

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A QBD With Design-of-Experiments Approach for Development of a State-of-the-Art Uplc Purity Method for Carbamazepine

Cited by 14 publications

References 7 publications

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

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

Effective Air‐Spray Deposition of Thin Films Obtained by Sol–Gel Process onto Complex Pieces of Sanitary Ware

Application of capability indices and control charts in the analytical method control strategy

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