Assay method for quality control and stability studies of a new anti‑diabetic and anti‑dyslipidemic flavone (S002‑853)*

Abstract

Background: Flavonoid‑rich extract of the plant is long known for its anti‑diabetic activities in traditional medicine. S002‑853, a new flavone derivative synthesized by Central Drug Research Institute (CDRI) has been used for the present study.Objectives: The present study aimed at development of an assay method for quality control (QC) and stability studies of a new anti‑diabetic and anti‑dyslipidemic agent CDRI compound S002‑853.Materials and Methods: A validated high‑performance liquid chromatography analysis method for S002‑853 was developed for in process QC and stability studies. The separation was achieved on a RP‑C18 (25 cm × 0.4 cm, 5 µm, Phenomenex) at 240 nm with flow rate of 1.0 ml/min. This method was applied successfully in establishing forced degradation and drug‑excipient testing protocols as per International Conference on Harmonization guidelines.Results: The result of estimation and stress testing studies indicated a high degree of selectivity of this method. S002‑853 was most stable at pH 7 and under photolytic conditions. The temperature degradation pattern of S002‑853 was found to follow the zero order degradation.Conclusion: The method described is easy and simple hence can be easily reproduced. This method can be very useful for bulk manufacture QC, and drug development process.

Keywords: Anti‑diabetic; anti‑dyslipidemic; flavone derivative; high performance liquid chromatography; in process quality control A B S T R A C T