Abstract
Objective: A stability-indicating reverse-phase high-performance liquid chromatographic method was developed and validated for the analysis of apigenin and luteolin. The degradation behavior of apigenin and luteolin was investigated under different stress conditions as recommended by the International Conference on Harmonization (ICH).
 Methods: In the present study, a reversed-phase high-performance liquid chromatography method was developed and the resolution of the plant constituents was successfully achieved using Hibar Lichrospher C8 column with ultraviolet detector at a wavelength of 269 nm. The mobile phase consisted of methanol and 0.5% trifluoroacetic acid (80:20 v/v) at a flow rate of 1.0 ml/min. Both apigenin and luteolin were subjected to various stress degradation studies such as oxidation, acid and alkaline hydrolysis, and photolytic degradation.
 Results: The proposed method was found to be linear (1–5 μg/ml) with the linear correlation coefficient of R2=0.99. Although the degradation products of stressed conditions were not identified, the methods were able to detect the changes due to stress condition.
 Conclusion: The method provides good sensitivity and excellent precision and reproducibility. Forced degradation studies on apigenin and luteolin give information about their storage and intrinsic stability conditions considering the advanced pharmaceutical aspects of formulations.
Highlights
Stability plays an important role in the herbal drug development process
If instability of an herbal drug product leads to these unwelcome effects on patients, it could lead to expensive costs to manufacturers as they attempt to discover the reasons for instability and methods of minimizing them
Chemical and solvents Apigenin and luteolin reference substances were procured from Natural Remedies, Bangalore
Summary
Stability plays an important role in the herbal drug development process. It explains several factors that affect the expiration dating of herbal drug products including the chemical and physical stability during the preclinical formulation stages, process development, packaging development, and post-marketing life. The evaluation of the physicochemical stability of a given herbal product requires an understanding of the physical and chemical properties of the drug substance. Lack of drug substance or drug product stability may affect the purity, potency, and safety of the drug product [1]. Instability may lead to the formation of toxic degradants. If instability of an herbal drug product leads to these unwelcome effects on patients, it could lead to expensive costs to manufacturers as they attempt to discover the reasons for instability and methods of minimizing them
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