Kumar, M (2014) Forced Degradation Studies of Alverine Citrate 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 a degradation product is defined as a chemical change in the drug molecule brought about over time and/or by action of, e.g., light, temperature, pH, or water or by reaction with an excipient and/or the immediate container/closure system. Stress testing is conducted to provide data on forced decomposition products and decomposition mechanisms. The severe conditions that may be encountered during distribution can be covered by stress testing. Aim of the study is to conduct “FORCED DEGRADATION STUDIES OF ALVERINE CITRATE IN BULK AND FORMULATION BY UV, IR SPECTROPHOTOMETRY, TLC, AND RP-HPLC METHOD”. The study comprises of the following: To perform the Alkali hydrolysis, Oxidative degradation, and Thermal and Photolytic degradation. Quantification of degraded samples 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. The study comprises of 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. Every procedure was repeated three times. Various stress conditions were tried to study the stability of Alverine citrate. The stress conditions used are Alkali, Acid hydrolysis, Oxidative degradation, Thermal and Photolytic degradation. The results of the studies are In intraday hydrolytic degradation, bulk underwent more degradation compared to sample from 30mins to 90mins study. In interday acid degradation, the assay values of bulk and sample were found to be 15.1% and 56.0% respectively, at the end of 5th day degradation. Complete degradation was observed in interday oxidative degradation. It shows that Alverine citrate is vulnerable to oxidative condition. Moderate amount of degradation was observed in both Photolytic and Thermal degradation. IR spectrum shows that no functional group changes were observed in both Photolytic and Thermal degradation. HPLC chromatogram shows that formation of impurities in intraday oxidative degradation. Interday oxidative degradation chromatogram shows complete degradation and more amounts of degradation products. No impurity peak was observed in both Photolytic and Thermal degradation chromatogram. No secondary spots were observed in TLC but difference in Rf value was observed. All the observations show Alverine citrate is vulnerable to Alkali hydrolysis, Oxidation, Thermal and Photolytic degradation.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Alverine Citrate; UV, IR Spectrophotometry; TLC; RP-HPLC Method |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Oct 2017 06:49 |
| Last Modified: | 20 Oct 2017 06:49 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3710 |
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