Stability-Indicating Assay Method for Estimation of Curcumin and its Degradants by RP-UHPLC Method
Vicky Anthony, Ritika Sahu, SK Jain, RamSingh Bishnoi and Deepti Jain
Published: February 05, 2022
Abstract
In this study stability-indicating assay method was developed and validated forestimation of curcumin and its degradation products as per ICH guidelines using RP-UHPLC.
For this the curcumin was subjected to forced degradation study under various stress conditions of hydrolysis (acidic, neutral and alkaline), oxidation, and thermal and photolytic as recommended by ICH Q1A (R2) guideline. A chromatographic method was developed for the estimation of curcumin in presence of its degradants. The chromatographic separation was obtained with Hypersil GOLD, C-18 reverse phase column (150mm×4.6mm×3μ) at flow rate 1 mL/min with mobile phase (Acetonitrile: Water:70:30). The pH of mobile phase was adjustedto 3.0 using formic acid. The peak was observed at 2.44 minutes at λmax 425nmusingdiode array detector.
The method has been validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and robustness. The linearity obtained in the range of 2-10μg/ml. LOD was found to be 50ng/ml. Further it was concluded that the curcumin is highly susceptible to oxidation, alkaline and neutral hydrolysis, slightly prone to thermal and photolysis, whereas stable towards acidic hydrolysis.
Keywords: RP-UHPLC method; Stability Indicating Assay Method; Forced Degradation study; Determination of Curcumin; Stability of Curcumin; Analytical method development