Forced Degradation Studies for Glycopyrrolate, Formoterol & Budesonide By UPLC

Authors

  • Chowdeswari Darugu Darugu Research Scholar, Department of Chemistry, Andhra University TDR-HUB & Assistant Professor in Chemistry, Sir C R Reddy College of Engineering, Eluru
  • B. Prasada Rao Department of Physics, S.V.L.N.S. Government Degree College, Bheemunipatnam, Visakhapatnam.
  • Ch.S. Anuradha Lecturer in Chemistry, Dr.V.S.Krishna Government Degree and PG College (A), Visakhapatnam -530013 India.
  • J. Santosh kumar Assistant professor, Department of chemistry, Dr. L.B. College, Visakhapatnam.
  • S. Shobha Rani Principal, Vishaka Government Degree College for women, Visakhapatnam.

DOI:

https://doi.org/10.15379/ijmst.v10i5.3579

Keywords:

Degradation; Drug substance; Stability; Safety; Testing; ICH guidelines, FDA

Abstract

Forced degradation studies include the degradation of new drug substance and drug product at conditions more severe than accelerated conditions. These studies illustrate the chemical stability of the molecule which further facilitates the development of stable formulation with suitable storage conditions. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc.

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Published

2023-11-21

How to Cite

[1]
C. D. Darugu, B. P. . Rao, C. . Anuradha, J. S. . kumar, and S. S. . Rani, “Forced Degradation Studies for Glycopyrrolate, Formoterol & Budesonide By UPLC”, ijmst, vol. 10, no. 5, pp. 860-866, Nov. 2023.