Assay method for quality control and stability studies of a new anti‑diabetic and anti‑dyslipidemic flavone (S002‑853)*
Arshi Naqvi1, Anuja Pandey1, Varsha Gupta1, Richa Malasoni1, Akansha Srivastava1, Rishi Ranjan Pandey1, M. Satyanarayana2, Ram Pratap2, Anil Kumar Dwivedi1★★ Corresponding author
- 1Division of Pharmaceutics, Central Drug Research Institute, India.
- 2Medicinal and Process Chemistry Division, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
CORRESPONDENCE
Anil Kumar Dwivedi
Division of Pharmaceutics, Central Drug Research Institute, India.
Received: 24-06-2014; Revised: 18-09-2014.
Volume 11, Issue 42s · pp. 53–59 · PUBLISHED 27 May 2015 · DOI: 10.4103/0973-1296.157689
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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.
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Naqvi, A., Pandey, A., Gupta, V., Malasoni, R., Srivastava, A., Pandey, R. R., Satyanarayana, M., Pratap, R., & Dwivedi, A. K. (2015). Assay method for quality control and stability studies of a new anti‑diabetic and anti‑dyslipidemic flavone (S002‑853)*. Pharmacognosy Magazine, 11(42s), 53–59. https://doi.org/10.4103/0973-1296.157689