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

Pahweenvaj Ratnatilaka Na Bhuket; Wisut Wichitnithad; Orawan Sudtanon; Pornchai Rojsitthisak

doi:10.1016/j.heliyon.2020.e04561

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

Heliyon. 2020 Aug 25;6(8):e04561. doi: 10.1016/j.heliyon.2020.e04561. eCollection 2020 Aug.

Authors

Pahweenvaj Ratnatilaka Na Bhuket¹, Wisut Wichitnithad^{1

2}, Orawan Sudtanon², Pornchai Rojsitthisak^{1

3}

Affiliations

¹ Natural Products for Ageing and Chronic Diseases Research Unit, Chulalongkorn University, Bangkok, 10330, Thailand.
² Department of Analytical Development, Pharma Nueva Co., Ltd., Bangkok, 10900, Thailand.
³ Department of Food and Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, 10330, Thailand.

Abstract

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.

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