title: 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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Arshi
authors.initials: A
authors.lastname: Naqvi
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Anuja
authors.initials: A
authors.lastname: Pandey
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Varsha
authors.initials: V
authors.lastname: Gupta
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Richa
authors.initials: R
authors.lastname: Malasoni
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Akansha
authors.initials: A
authors.lastname: Srivastava
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Rishi Ranjan
authors.initials: RR
authors.lastname: Pandey
authors.affiliation: Medicinal and Process Chemistry Division, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: M
authors.initials: M
authors.lastname: Satyanarayana
authors.affiliation: Medicinal and Process Chemistry Division, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Ram
authors.initials: R
authors.lastname: Pratap
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Anil Kumar
authors.initials: AK
authors.lastname: Dwivedi
keywords: Anti-diabetic; anti-dyslipidemic; flavone derivative; high performance liquid chromatography; in process quality control