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Pharmaceutical quality evaluation of dexamethasone tablets in Mwanza city, Tanzania

By: Contributor(s): Material type: TextTextPublisher number: Phone: +255 28 298 3384 Fax: +255 28 298 3386 Email: vc@bugando.ac.tz Website: www.bugando.ac.tz Language: English Language: Kiswahili Publication details: Mwanza, Tanzania: Catholic University of Health and Allied Sciences [CUHAS – Bugando] ©02.05.2022 Description: x; 23 Pages; Includes References and AppendicesSubject(s): Summary: Abstract: Background: Dexamethasone is a steroidal drug of the glucocorticoid class that produces anti-inflammatory and also immunosuppressant effects. Each tablet contains 0.5mg of API together with several excipients. The aim of this study was to perform a comparative study between different brands of dexamethasone tablets marketed in Mwanza by performing an assay test. Methodology: The study was a laboratory experimental study, in which identification and assay tests of 40 samples of dexamethasone tablets were done. A UV-Visible Spectrophotometer was used to perform both identification and assay tests. The prepared sample solutions were placed in the machine then sample peaks were compared with standard peak for identification. Assay test was done by reading the maximum absorbance of the sample and looking for concentration using the Beer- Lambert law. Results: In this study, all samples contained the active ingredient. According to the BP, a good quality dexamethasone tablet is the one with API content which ranges from 90 to 110%. Pursuant to our study, 15% of the samples did not meet the specifications stated in the pharmacopoeia. All of these samples belonged to one brand which is the most selling compared to the other. Conclusion: Conclusively, most of the samples in this study complied with the specifications set in the official formularies. The six samples which did not comply with the set limits can be indicative of the necessary adjustments needed to be done during manufacturing or storage of the drugs
Item type: UNDERGRADUATE DISSERTATIONS
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Item type Current library Collection Copy number Status Barcode
UNDERGRADUATE DISSERTATIONS MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO NFIC CRECU/2271 1 CRECU/2271
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Abstract:

Background: Dexamethasone is a steroidal drug of the glucocorticoid class that produces anti-inflammatory and also immunosuppressant effects. Each tablet contains 0.5mg of API together with several excipients. The aim of this study was to perform a comparative study between different brands of dexamethasone tablets marketed in Mwanza by performing an assay test.

Methodology: The study was a laboratory experimental study, in which identification and assay tests of 40 samples of dexamethasone tablets were done. A UV-Visible Spectrophotometer was used to perform both identification and assay tests. The prepared sample solutions were placed in the machine then sample peaks were compared with standard peak for identification. Assay test was done by reading the maximum absorbance of the sample and looking for concentration using the Beer- Lambert law.

Results: In this study, all samples contained the active ingredient. According to the BP, a good quality dexamethasone tablet is the one with API content which ranges from 90 to 110%. Pursuant to our study, 15% of the samples did not meet the specifications stated in the pharmacopoeia. All of these samples belonged to one brand which is the most selling compared to the other.

Conclusion: Conclusively, most of the samples in this study complied with the specifications set in the official formularies. The six samples which did not comply with the set limits can be indicative of the necessary adjustments needed to be done during manufacturing or storage of the drugs

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