Anjul Agarwal
anjul_g@rediffmail.com
International Journal of ChemTech Research
IJCTR
0974-4290
2455-9555
10.20902/CT
http://www.sphinxsai.com/chemtech.php
2018
11
11
Development and Validation of Stability Indicating HPLC Method for Epigallocatechin Gallate (EGCG)
Deepali
Bansode
1
Harshali
Shinde
1
Vividha
Dhapte
1
Department of Pharmaceutical Chemistry, Department of Quality Assurance
Techniques& Department of Pharmaceutics, Bharati Vidyapeeth University,
Poona College of Pharmacy, Pune, Maharashtra, India-411038
2018
56
64
111107
10.20902/IJCTR.2018.111107
http://dx.doi.org/10.20902/IJCTR.2018.111107
A new, economical, precise and accurate stability indicating HPLC method
wasdeveloped and validated for the EGCG as per ICH guidelines. The study deals with
development and validation of HPLC method for estimation of EGCG. Chromatographic
separation was performed on C18column fitted with guard column using mobile phase
Methanol: Acetic acid (0.1%)(75:25v/v). The wavelength used for detection was 276 nm.
Regression plots revealed a linearrelationship in the concentration range of 20-120 μg/ml. The
retention time for EGCG was found to be 5.3min.TheLOD and LOQ were found to be5.07 and
15.27 μg/ml respectively. The method was validated as per International Conference on
Harmonization (ICH) guidelines, demonstrating to be accurate and precise within the
corresponding linearity range of titledanalytes. Stability of the drug was studied by exposing
drug to acid, alkali, oxidative, photolytic and thermal conditions. Relevant degradation was
found to take place under theseconditions. The proposed method has been validated as per
ICH Q2 (R1) guidelines. This methodcan be used for routine quality control analysis of
EGCG
http://sphinxsai.com/2018/ch_vol11_no11/1/(56-64)V11N11CT.pdf
Validation
Epigallocatechin Gallate (EGCG)
HPLC
Stability indicating method
https://pubchem.ncbi.nlm.nih.gov/compound/_-_-Epigallocatechin_gallate
http://www.chemspider.com/Chemical-Structure.58575.html
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