Development and Validation Dissolution Analytical Method of Nimesulide beta-Cyclodextrin 400 mg Tablet

The nimesulide (N-(4-nitro-2-phenoxyphenyl)methanesulfonamide) belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs and category II of the biopharmaceutical classification, The complexation of nimesulide with b-cyclodextrin is a pharmacological strategy to increase the solubility of the drug The objective of this study was to develop and validate an analytical methodology for dissolving the nimesulide beta-cyclodextrin 400 mg tablet and meets the guidelines of ANVISA for drug registration purposes. Once developed, the dissolution methodology was validated according to the RE of parameters no.  899/2003. In the development of the method it was noted that the duration of the dissolution test was 60 minutes, the volume and the most suitable dissolution medium was 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 was the most appropriate to evaluate the dissolution of the drug. Spectrophotometric methodology was used to quantify the percentage of dissolved drug. The wavelength was 390 nm using the quantification. The validation of the methodology, system suitability parameters, specificity/selectivity, linearity, precision, accuracy and robustness were satisfactory and proved that the developed dissolution methodology was duly executed. DOI: http://dx.doi.org/10.17807/orbital.v8i5.82

Development and Validation Dissolution Analytical Method of Nimesulide beta-Cyclodextrin 400 mg Tablet

The nimesulide (N-(4-nitro-2-phenoxyphenyl)methanesulfonamide) belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs and category II of the biopharmaceutical classification, The complexation of nimesulide with b-cyclodextrin is a pharmacological strategy to increase the solubility of the drug The objective of this study was to develop and validate an analytical methodology for dissolving the nimesulide beta-cyclodextrin 400 mg tablet and meets the guidelines of ANVISA for drug registration purposes. Once developed, the dissolution methodology was validated according to the RE of parameters no.  899/2003. In the development of the method it was noted that the duration of the dissolution test was 60 minutes, the volume and the most suitable dissolution medium was 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 was the most appropriate to evaluate the dissolution of the drug. Spectrophotometric methodology was used to quantify the percentage of dissolved drug. The wavelength was 390 nm using the quantification. The validation of the methodology, system suitability parameters, specificity/selectivity, linearity, precision, accuracy and robustness were satisfactory and proved that the developed dissolution methodology was duly executed. DOI: http://dx.doi.org/10.17807/orbital.v8i5.82

Perfil Químico do Óleo Volátil das Folhas de Erythroxylum deciduum A. St.-Hil. (Erythroxylaceae), Coletadas em Goiânia, Goiás

The Erythroxylum (Erythroxylaceae) genus has about 130 species, which can be found in forest environments and cerrado. Studies with Erythroxylum species led to the isolation of secondary metabolites such as flavonóides, alkaloids, tannins, terpenes and phenylpropanoids that exhibit anti-oxidant activity, anti-carcinogenic, anti-inflammatory activity among others to be operated with pharmaceutical purposes. In order to contribute to the chemical elucidation of Erythroxylum genus, this research aimed to evaluate the composition of the essential oil from the leaves of E. deciduum A. St.-Hil. The botanical material was collected in the peri-urban area of the city of Goiânia, Goiás, Brazil, it was identified and had a voucher specimen deposited in the Herbarium of the State University of Goiás. The essential oil extraction was performed by hydrodistillation adapted by Clevenger. The essential oil chemical composition was determined by gas chromatography-mass spectrometry (GC/ MS). The species studied showed as major components: himachalol (3.49%), sandaracopimarinal (4.87%), ethyl 8cedren-13-ol (5.65%) and ternina (6.37%) whose description on the literature, points to the antimicrobial and allelopathic activity. Thus, These volatile components may be viable in obtaining bioproducts or as prototypes in the synthesis of compounds of pharmacotherapeutic, food and agricultural interest.O gênero Erythroxylum (Erythroxylaceae) possui cerca de 130 espécies, as quais podem ser encontradas em ambientes florestais e de cerrado sensu stricto. Estudos realizados com as espécies do gênero Erythroxylum levaram ao isolamento de metabólitos secundários como flavonóides, alcalóides, taninos, terpenos e fenilpropanóides que apresentam atividades antioxidantes, anticancerígenas, atividade anti-inflamatória, dentre outras, a serem exploradas com propósitos farmacêuticos. No intuito de contribuir para a elucidação química do gênero Erythroxylum, o presente trabalho teve como objetivo avaliar a composição química do óleo volátil das folhas de E. deciduum A. St.-Hil. O material botânico foi coletado na região periurbana do município de Goiânia, Goiás, Brasil, foi identificado e teve uma exsicata depositada no Herbário da Universidade Estadual de Goiás. A extração do óleo volátil foi realizada através de hidrodestilação por Clevenger adaptado. A composição química do óleo volátil foi determinada por cromatografia gasosa acoplada à espectrometria de massas (CG/EM). A espécie em estudo apresentou como componentes majoritários: himachalol (3,49%), sandaracopimarinal (4,87%), acetato de 8-cedren-13-ol (5,65%) e ternina (6,37%) cuja descrição na literatura aponta para a atividade antimicrobiana e alelopática. Estes constituintes voláteis podem ser viáveis na obtenção de bioprodutos ou como protótipos na síntese de compostos de interesse farmacoterapêutico, alimentício e agronômico