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Brazilian Journal of Pharmaceutical Sciences
versión impresa ISSN 1984-8250
SHAH, Ritesh et al. Development and validation of dissolution method for carvedilol compression-coated tablets. Braz. J. Pharm. Sci. [online]. 2011, vol.47, n.4, pp. 899-906. ISSN 1984-8250. http://dx.doi.org/10.1590/S1984-82502011000400027.
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.
Palabras clave : Carvedilol [coated tablets]; Compression coated tablets [dissolution]; pH 6.8 citric-phosphate buffer; Hydrochloric acid; Sodium lauryl sulphate.