A stability-indicating UPLC method for the determination of curcumin diethyl disuccinate, an ester prodrug of curcumin, in raw materials.

Analytical chemistry Chromatography Curcumin diethyl disuccinate Optical spectroscopy Pharmaceutical chemistry Pharmaceutical science Prodrug Stability-indicating method UPLC Validation

Journal

Heliyon
ISSN: 2405-8440
Titre abrégé: Heliyon
Pays: England
ID NLM: 101672560

Informations de publication

Date de publication:
Aug 2020
Historique:
received: 20 05 2020
revised: 05 07 2020
accepted: 22 07 2020
entrez: 9 9 2020
pubmed: 10 9 2020
medline: 10 9 2020
Statut: epublish

Résumé

A stability-indicating reversed-phase ultra-performance liquid chromatographic (UPLC) method for quantitative analysis of curcumin diethyl disuccinate (CDD) in raw materials was developed for applications in product development and quality control. Chromatographic separation was performed using the Waters ACQUITY UPLC® H-Class system consisting of an ACQUITY UPLC® BEH C18 (1.7 μm, 2.1 × 50 mm) column and a photodiode array detector set at a wavelength of 400 nm. The mobile phase consisting of 2%v/v acetic acid in water and acetonitrile was delivered at a flow rate of 0.3 mL/min under gradient elution program. The method was validated according to the ICH Q2(R1) guideline for the validation of analytical procedures. The method was found to be linear over the concentration range of 8-12 μg/mL with the coefficient of determination >0.995. The accuracy of the method established as %recovery ranged from 98.3 - 100.8%. The precision of the method expressed as %CV was found to be <1%. The coelution of degradation products from six stress test conditions was not observed. The method was robust under the variation of chromatographic parameters. The method was successfully applied in the determination of CDD content in raw materials.

Identifiants

pubmed: 32904269
doi: 10.1016/j.heliyon.2020.e04561
pii: S2405-8440(20)31405-5
pii: e04561
pmc: PMC7452553
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e04561

Informations de copyright

© 2020 The Authors.

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Auteurs

Pahweenvaj Ratnatilaka Na Bhuket (P)

Natural Products for Ageing and Chronic Diseases Research Unit, Chulalongkorn University, Bangkok, 10330, Thailand.

Wisut Wichitnithad (W)

Natural Products for Ageing and Chronic Diseases Research Unit, Chulalongkorn University, Bangkok, 10330, Thailand.
Department of Analytical Development, Pharma Nueva Co., Ltd., Bangkok, 10900, Thailand.

Orawan Sudtanon (O)

Department of Analytical Development, Pharma Nueva Co., Ltd., Bangkok, 10900, Thailand.

Pornchai Rojsitthisak (P)

Natural Products for Ageing and Chronic Diseases Research Unit, Chulalongkorn University, Bangkok, 10330, Thailand.
Department of Food and Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, 10330, Thailand.

Classifications MeSH