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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Forced Degradation Studies on Empagliflozin Tablets and Empagliflozin (Raw Material) |
| Authors Name: | Anish Bhattarai , Shiba S Morris , Anisha Arya |
| Unique Id: | IJSDR2308164 |
| Published In: | Volume 8 Issue 8, August-2023 |
| Abstract: | 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. |
| Keywords: | Forced Degradation Studies, ICH Guidelines, Empagliflozin, Stress conditions, |
| Cite Article: | "Forced Degradation Studies on Empagliflozin Tablets and Empagliflozin (Raw Material)", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 8, page no.1118 - 1129, August-2023, Available :http://www.ijsdr.org/papers/IJSDR2308164.pdf |
| Downloads: | 000338719 |
| Publication Details: | Published Paper ID: IJSDR2308164 Registration ID:207983 Published In: Volume 8 Issue 8, August-2023 DOI (Digital Object Identifier): Page No: 1118 - 1129 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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