Degradation Study of Dapagliflozin in API by Spectro-scopic Method

Authors

  • Dr.(Mrs.)M.D. Game Department of Pharmaceutical Quality Assurance, Vidayabharti College of Pharmacy, C. K. Naidu Road, Sant Gadge Baba Amravati University, 444602, Maharashtra, India
  • Naglaxmi Bopudi Department of Pharmaceutical Quality Assurance, Vidayabharti College of Pharmacy, C. K. Naidu Road, Sant Gadge Baba Amravati University, 444602, Maharashtra, India

Keywords:

Dapagliflozin, UV- Spectroscopy, API, International Conference on Harmonization

Abstract

A simple, sensitive, precise, accurate, economic and rapid  visible spectroscopic method has been developed for estimation of dapagliflozin in API.Dapagliflozin was subjected to different stress conditions as per ICH guideline Q1A (R2). A stability- indicating UV Spectroscopic method has been developed for analysis of the drug in the presence of the degradation products. Degradation of Dapagliflozin was studied in acid, alkaline, hydrogen peroxide, photolytic, thermal and neutral conditions. The amount of degraded drug was calculated by taking absorbance at 272 nm.The drug was found to be more liable to decompositions in acidic,alkaline,oxidative , neutral medium than in photolytic and thermal conditions.

Downloads

Download data is not yet available.

References

Edward Chao C, Robert Henry R. SGLT2 inhibitors a novel strategy for diabetes treatment. Nature Re-views Drug Discovery 2010; 10: 1-9.

Sanagapati M, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method Development and Validation of Dapagliflozin in API by RP- HPLC and UV-Spectroscopy. Int J Pharm Sci and drug Res.2014;6(3):250-2.

Aubry AF, Gu H, Magnier R, Morgan L, Xu X, Tirmenstein M, Wang B, Deng Y, Cai J, Couerbe P, Arnold M. Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis 2010;2(12):2001-2009.

Beckett AH, Stenlake JB. Practical pharmaceutical chemistry part II, New Delhi: CBS publishers and distributers. 1997, 4th ed,281-306.

A. Kasture, S. Wadodkar, Practical Pharmaceutical Chemistry – II: Nirali Prakashan fourteenth edition; 2007; 9-10

Validation of Analytical Procedures: Text and Methodology (Q2R1), ICH Harmonised Tripartite Guideline.

Stability Testing of New Drug Substances and Produts (Q1AR2), ICH Harmonised Tripartite Guideline.

T. Snape, A. Astles, J. Davies. Understanding the chemical basis of drug stability and degradation. The pharmaceutical Journal 2010: 285: p.416.

S. Singh, M. Bakshi. Guidance on conduct of stress tests to determine inherent stability of drugs, pharm. Technol 2000: 24: p.1-14.

Q1 A (R2) ICH guidelines, Stability Testing of New Drug Substances and Product, Q1 A (R2), International conference on Harmonization, Geneva ICH, 2003.

Published

2018-02-14
Statistics
194 Views | 474 Downloads
Citatons

How to Cite

Dr.(Mrs.)M.D. Game, and Naglaxmi Bopudi. “Degradation Study of Dapagliflozin in API by Spectro-Scopic Method”. International Journal of Pharmaceutics and Drug Analysis, vol. 6, no. 2, Feb. 2018, pp. 84-88, https://ijpda.org/index.php/journal/article/view/330.

Issue

Section

Research Articles
Share |