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Article

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

  1. 1Division of Pharmaceutics, Central Drug Research Institute, India.
  2. 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.

anilcdri@gmail.com

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