1. Assay method for quality control and stability studies of a new anti-diabetic and anti-dyslipidemic flavone (S002-853).
- Author
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Naqvi, Arshi, Pandey, Anuja, Gupta, Varsha, Malasoni, Richa, Srivastava, Akansha, Pandey, Rishi Ranjan, Satyanarayana, M., Pratap, Ram, and Dwivedi, Anil Kumar
- Subjects
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FLAVONES , *HYPOGLYCEMIC agents , *DYSLIPIDEMIA , *HIGH performance liquid chromatography - 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 x 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 tofollow 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. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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