Implementation of design of experiments for optimization of forced degradation conditions and development of a stability‐indicating high‐performance liquid chromatography method for sepiwhite

Sepiwhite is a novel anti‐pigmenting agent that is derived from fatty acid and phenylalanine and used for hyperpigmentation induced by light exposure or inflammation. In this study, a simple and validated high‐performance liquid chromatography method for the quantitation of sepiwhite was developed....

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Bibliographic Details
Published in:Journal of separation science 2021-12, Vol.44 (24), p.4299-4312
Main Authors: Davoodi, Javid, Majidi, Sina, Jahani, Maryam, Tayarani‐Najaran, Zahra, Golmohammadzadeh, Shiva, Kamali, Hossein
Format: Article
Language:English
Subjects:
Chromatography
Chromatography, High Pressure Liquid - methods
Computer Simulation
cytotoxicity
Degradation
degradation products
Dermatologic Agents - chemistry
Dermatologic Agents - therapeutic use
Design of experiments
Design optimization
Fatty acids
Heavy metals
HPLC method validation
Humans
Hyperpigmentation - prevention & control
Limit of Detection
Liquid chromatography
Phenylalanine
Photolysis
Quality control
Reproducibility of Results
sepiwhite
stability‐indicating method
Toxicity
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Summary:Sepiwhite is a novel anti‐pigmenting agent that is derived from fatty acid and phenylalanine and used for hyperpigmentation induced by light exposure or inflammation. In this study, a simple and validated high‐performance liquid chromatography method for the quantitation of sepiwhite was developed. Optimized forced degradation of sepiwhite at thermal, acid/base, photolysis, oxidative, and heavy metal ions conditions were evaluated and the effect of each of them on production of specific 10%–30% degradants was studied by the approach of design of experiments. Sepiwhite accelerated study was conducted and toxicity of sepiwhite at each condition was tested. An optimized high‐performance liquid chromatography method was validated by a face‐centered central composition design. Ten different degradants were identified from sepiwhite and degradation behavior under different conditions was studied. Sepiwhite and its degradant products show no cytotoxicity. This optimized high‐performance liquid chromatography method can be applied for quality control assay and sepiwhite degradation behavior may be considered in the manufacturing of sepiwhite products.
ISSN:1615-9306
1615-9314
DOI:10.1002/jssc.202100388