Forced Degradation Studies on Empagliflozin Tablets and Empagliflozin (Raw Material)

Anish Bhattarai , Shiba S Morris , Anisha Arya

Forced Degradation Studies, ICH Guidelines, Empagliflozin, Stress conditions,

The purpose of this research is to perform forced degradation of Empagliflozin. A forced degradation study of Empagliflozin (raw material and tablet-10 mg & 25mg) were carried out simultaneously. The drugs were subjected to various degradation conditions like acid degradation, base degradation, Oxidative degradation, thermal degradation, and photolytic degradation for 1,3,5 days. Force degradation studies was performed as per ICH Guidelines, Q1A (R2), Stability testing of New Drugs Substances and products. Percentage degradation was calculated by performing assay (amount of the drug) in each condition. A simple, accurate, validated, precise and sensitive analytical RP-HPLC method was selected for analysis of drug content. Both raw material and tablet were stable in the degradation study. But Degradation of raw material was slightly higher in comparison to dosage form. For raw material basic stress degraded highest amount of the drug. But 10mg Empagliflozin tablets degraded highest in photolytic stress & 25mg degraded highest amount of the drug in thermal condition. No sample degraded more than 15%. Hence from this study it can be concluded that both raw material and dosage form of Empagliflozin are physically and chemically stable for their shelf life.

Published Paper   E-Certificate

"Forced Degradation Studies on Empagliflozin Tablets and Empagliflozin (Raw Material)", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.8, Issue 8, page no.1118 - 1129, August-2023, Available :https://ijsdr.org/papers/IJSDR2308164.pdf

Volume 8 Issue 8, August-2023

Pages : 1118 - 1129

Paper Reg. ID: IJSDR_207983

Published Paper Id: IJSDR2308164

Downloads: 000347199

Research Area: Pharmacy

Country: Arariya, Bihar, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2308164

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2308164

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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