Maheshkumar, G (2014) Forced Degradation Studies of Cefuroxime Axetil in Bulk and Formulation by UV, IR Spectrophotometry, TLC, and RP-HPLC Method. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
The present study the stability of a drug product or a drug substance is a critical parameter which may affect purity, potency and safety. Changes in drug stability can risk patient safety by formation of a toxic degradation product(s) or deliver a lower dose than expected. Therefore it is essential to know the purity profile and behavior of a drug substance under various environmental conditions The aim of the study is to conduct “FORCED DEGRADATION STUDIES OF CEFUROXIME AXETIL IN BULK AND FORMULATION BY UV, IR SPECTROPHOTOMETRY, TLC, AND RP-HPLC METHOD” and to evaluate the stability of Cefuroxime axetil in variety of stress conditions. Stability plays an important role in storage of drugs. The study includes the following: To perform the Alkali hydrolysis, Oxidative degradation, and Thermal and Photolytic degradation. Quantification of degraded product by UV and HPLC. Comparing the results of bulk and sample with standard. Identification of Degraded samples by TLC. Identification of changes in functional group present in the degraded samples by IR. CONCLUSION: The Alkali hydrolysis, Oxidative degradation, and Thermal and Photolytic degradation were performed. Degraded samples were quantified by UV spectroscopy and HPLC. The results of bulk and sample compared with standard. Degraded samples were identified by TLC. Functional group changes in degraded samples were identified by IR. Quantification of Cefuroxime axetil in bulk and formulation was done by UV spectroscopy and HPLC method. Interday studies of Photolytic and Thermal degradation was evaluated by IR spectroscopy to detect changes in functional group. Cefuroxime axetil bulk and formulation were subjected to Hydrolytic degradation, Oxidative degradation, Thermal and Photolytic degradation. The main findings of the study are Compared to sample, standard has undergone more amount of degradation in intraday alkali degradation. Complete degradation was observed in interday alkali hydrolytic degradation on 3rd day. It indicates that Cefuroxime axetil is vulnerable to alkali hydrolysis. Complete degradation was observed in interday acid hydrolytic degradation. It shows Cefuroxime axetil is sensitive to acid. Oxidative degradative study indicates Cefuroxime axetil is vulnerable to oxidation.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Cefuroxime Axetil; UV, IR Spectrophotometry; TLC; RP-HPLC Method |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Oct 2017 06:50 |
| Last Modified: | 20 Oct 2017 06:50 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3711 |
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