Development and validation of dissolution method for carvedilol compression-coated tablets
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| 1. | Title | Title of document | Development and validation of dissolution method for carvedilol compression-coated tablets |
| 2. | Creator | Author's name, affiliation, country | Ritesh Shah; Maliba Pharmacy College; Department of Pharmaceutics; |
| 2. | Creator | Author's name, affiliation, country | Sachin Patel; Maliba Pharmacy College; Department of Pharmaceutics; |
| 2. | Creator | Author's name, affiliation, country | Hetal Patel; Maliba Pharmacy College; Department of Pharmaceutics; |
| 2. | Creator | Author's name, affiliation, country | Sonia Pandey; Maliba Pharmacy College; Department of Pharmaceutics; |
| 2. | Creator | Author's name, affiliation, country | Shailesh Shah; Maliba Pharmacy College; Department of Pharmaceutics; |
| 2. | Creator | Author's name, affiliation, country | Dinesh Shah; Maliba Pharmacy College; Department of Pharmaceutics; |
| 3. | Subject | Discipline(s) | |
| 3. | Subject | Keyword(s) | Carvedilol^i1^scoated tabl;Compression coated tablets^i1^sdissolut;pH 6.8 citric-phosphate buffer;Hydrochloric acid;Sodium lauryl sulphate |
| 4. | Description | Abstract | The present study describes the development and validation of a dissolution method for carvedilol compression-coated tablets. Dissolution test was performed using a TDT-06T dissolution apparatus. Based on the physiological conditions of the body, 0.1N hydrochloric acid was used as dissolution medium and release was monitored for 2 hours to verify the immediate release pattern of the drug in acidic pH, followed by pH 6.8 in citric-phosphate buffer for 22 hours, to simulate a sustained release pattern in the intestine. Influences of rotation speed and surfactant concentration in medium were evaluated. Samples were analysed by validated UV visible spectrophotometric method at 286 nm. 1% sodium lauryl sulphate (SLS) was found to be optimum for improving carvedilol solubility in pH 6.8 citric-phosphate buffer. Analysis of variance showed no significant difference between the results obtained at 50 and 100 rpm. The discriminating dissolution method was successfully developed for carvedilol compression-coated tablets. The conditions that allowed dissolution determination were USP type I apparatus at 100 rpm, containing 1000 ml of 0.1N HCl for 2 hours, followed by pH 6.8 citric-phosphate buffer with 1% SLS for 22 hours at 37.0 ± 0.5 ºC. Samples were analysed by UV spectrophotometric method and validated as per ICH guidelines. |
| 5. | Publisher | Organizing agency, location | Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
| 6. | Contributor | Sponsor(s) | |
| 7. | Date | (YYYY-MM-DD) | 2011-12-01 |
| 8. | Type | Status & genre | Peer-reviewed Article |
| 8. | Type | Type | |
| 9. | Format | File format | |
| 10. | Identifier | Uniform Resource Identifier | https://www.revistas.usp.br/bjps/article/view/10954 |
| 10. | Identifier | Digital Object Identifier (DOI) | http://dx.doi.org/10.1590/S1984-82502011000400027 |
| 11. | Source | Title; vol., no. (year) | Brazilian Journal of Pharmaceutical Sciences (Impresso); Vol 47, No 4 (2011) |
| 12. | Language | English=en | en |
| 13. | Relation | Supp. Files | |
| 14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
| 15. | Rights | Copyright and permissions |
Copyright (c) 2017 Brazilian Journal of Pharmaceutical Sciences (Impresso) This work is licensed under a Creative Commons Attribution 4.0 International License. |