Desenvolvimento e validação de um método analítico para avaliar a dissolução de comprimidos de Nimesulida Beta-Ciclodextrina

Abstract

Nimesulide belongs to the class of anti-inflammatory non-steroidal drugs (NSAIDs) and category II of the biopharmaceutical classification. Complexation of nimesulide with β-cyclodextrin is a pharmacological strategy to increase the solubility of the drug. The objective of this study was to develop and validate an analytical method to evaluate the dissolution of β-cyclodextrin nimesulide tablets. During the development of dissolution method to evaluate polymorphism and drug solubility in different dissolution media within the physiological pH range of 1,2 to 6,8 are essential. The polymorphic form was present in the samples I and the mixture of nimesulide with βcyclodextrin increased the solubility of the drug by more than 10 times. Once developed, the dissolution method was validated according to the parameters of Resolution No . 899/2003 of ANVISA. In the development of the method it has been found that the duration of the dissolution test was 60 minutes, the volume and the medium more suitable dissolution were 900 ml of aqueous solution of sodium lauryl sulfate 1% (w/v). It was also noted that rotation of 100 rpm and the paddle apparatus have been most suitable for assessment of drug dissolution. Spectrophotometry was used to quantify the percentage of dissolved drug. The wavelength of 390 nm was used for quantification. In method validation the adequacy of the system parameters of specificity/selectivity, linearity, precision, accuracy and robustness were satisfactory which proved that the developed dissolution methodology is appropriate to the intended use.