FIRST EDITION

Analysis of drugs requires standing search for reliable analytical techniques, essential to assure their identification and concentration in several matrices. In this context, the edition of scientific works has the objective of contributing with the researchers of the analytical area collaborating with the diffusion and knowledge related to this subject.The editorial team is celebrating the first volume of the journal Drug Analytical Research, a result of the effort of professors and collaborators who have taken up the challenge of expanding the analytical research involving therapeutic substances.The scope of the journal is focused on the analytical determination of drugs in different matrices, impurities, propositions of new analytical methods, as well as the systematic review of issues of separation and quantitative determination.At this moment, we would like to invite to access the website of the journal through the address (http://seer.ufrgs.br/index/php/dar) and appreciate the articles and reviews included in this first edition.Finally, we thank all those who supported this project, especially to Dra. Amanda Thomas Barden, who helped effectively in all stages of publication of this journal. Porto Alegre, August 28th, 2017Martin SteppeLead Editor                                                                                                                                                                                                                             

DETERMINATION OF WATER CONTENT IN TEA SAMPLES OF CYMBOPOGON CITRATUS S., MATRICARIA RECUTITA L., MENTHA SPP. AND PIMPINELLA ANISUM L. THROUGH GRAVIMETRIC AND THERMOGRAVIMETRIC METHODS

The excess of humidity in materials of plant origin allows the action of enzymes, which can cause degradation of chemical components and enable fungi and bacteria development. The humidity determination is one of the most important and most used measurements in food analysis, as it is tightly related to food quality, stability and composition. Teas are among humanity’s most popular and most broadly diffused drinks, being the most common form of phytoterapeutical products and a natural source of chemical substances with activity against a broad variety of ailments. Humidity determination in teas of Cymbopogon citratus S., Matricaria recutita L., Mentha spp. and Pimpinella anisum L was performed through pharmacopoeia-standards gravimetric analysis, drying by infrared radiation and thermogravimetry, and the results obtained by each method were compared. All humidity indexes obtained were in accordance with the currently available official specifications. Water content values obtained by the pharmacopoeia-standards assay, infrared radiation assay and thermogravimetry presented statistical difference between them, due to the methods’ technical features or the utilized materials’ physical characteristics; still the thermogravimetry and the infrared radiation assay were the methods that presented the least statistical difference between their results. The pharmacopoeia-standards method presented itself as the more adequate method for the determination of water content in materials of plant origin, like teas.The excess of humidity in materials of plant origin allows the action of enzymes, which can cause degradation of chemical components and enable fungi and bacteria development. The humidity determination is one of the most important and most used measurements in food analysis, as it is tightly related to food quality, stability and composition. Teas are among humanity’s most popular and most broadly diffused drinks, being the most common form of phytoterapeutical products and a natural source of chemical substances with activity against a broad variety of ailments. Humidity determination in teas of Cymbopogon citratus S., Matricaria recutita L., Mentha spp. and Pimpinella anisum L was performed through pharmacopoeia-standards gravimetric analysis, drying by infrared radiation and thermogravimetry, and the results obtained by each method were compared. All humidity indexes obtained were in accordance with the currently available official specifications. Water content values obtained by the pharmacopoeia-standards assay, infrared radiation assay and thermogravimetry presented statistical difference between them, due to the methods’ technical features or the utilized materials’ physical characteristics; still the thermogravimetry and the infrared radiation assay were the methods that presented the least statistical difference between their results. The pharmacopoeia-standards method presented itself as the more adequate method for the determination of water content in materials of plant origin, like teas

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

A finalidade deste estudo foi desenvolver e validar um método de dissolução para o fármaco lamotrigina na forma farmacêutica comprimido. Este método também foi utilizado para comparar o perfil de dissolução entre o Neural® e o produto de referência Lamictal®. O procedimento analítico foi realizado utilizando-se espectrofotometria de absorção no ultravioleta (267 nm) como forma de quantificação do fármaco. Após a determinação da solubilidade e das condições sink, os parâmetros selecionados foram: pás (50 rpm), 900 mL de ácido clorídrico 0.01 M e o tempo de 30 minutos (único ponto). Este método foi validado através da especificidade, linearidade, exatidão, precisão e robustez. A estabilidade da lamotrigina também foi avaliada no meio de dissolução.A dissolution test for tablets containing 100 mg of lamotrigine was developed and validated. The dissolution test was applied to compare the dissolution profile of Neural® with the reference product Lamictal®. The analysis procedure was carried out using a simple ultraviolet method at 267 nm. After the determination of solubility and sink conditions, the parameters selected were paddles at 50 rpm, 900 mL of 0.01 M hydrochloric acid, and 30 minutes duration (single point). This method was validated for specificity, linearity, accuracy, precision and robustness. Lamotrigine stability was also evaluated in dissolution medium

Dissolution Test for Mianserin Hydrochloride in Tablets

A dissolution test for mianserin hydrochloride in coated tablets containing 30 mg was developed and validated using a fast ultraviolet spectrophotometric method. The appropriate conditions were determinate after testing sink conditions, agitation spped and dissolution medium. The sink conditions tested showed that mianserin hydrochloride was soluble in 0.01 and 0.1 M hydrochloric acid (HCl), acetate buffer pH 4.1 and 5.0 and phosphate buffer pH 6.8. Then, dissolution tests were performed to investigate the drug release in each medium. Optimal conditions to carry out the dissolution test were 900 mL 0.1 M HCl and USP apparatus 2 (paddle) at 50 rpm stirring speed. The quantification method was also adapted and validated. The UV method showed specificity, linearity, precision and accuracy. The in vitro dissolution test can be used to evaluate the drug release profile and the data was used as an aid to establish a possible correlation with in vivo data

Evaluation of Physical-Chemical and Microbiological Stability of Fluconazole Oral Suspensions for Hospital Use

Fluconazole is an important drug in the treatment of cutaneous and systemic mycoses. The Hospital de Clínicas de Porto Alegre performs a derivation of fluconazole capsules to obtain an oral liquid formulation that is easily administered and whose dose can be adjusted. In order to replace the derivation for a formulation produced from an active pharmaceutical ingredient, this study sought to develop a liquid oral formulation, evaluate its physical chemical and microbiological stability and demonstrate suitability of the analytical method for the formulation assay. Seven different formulations of pharmaceutical suspension form were produced and evaluated for pH, viscosity, sedimentation volume and assay. The analytical method by High Performance Liquid Chromatography was demonstrated. Two most promising formulations were manipulated in the Farmácia Semi-Industrial do Hospital de Clínicas de Porto Alegre and stored in amber PET bottles under three different conditions: room temperature, under refrigeration (2 to 8 ºC) and in an oven (40 ° C). Samples were collected after 0, 7 and 14 days to evaluate physical-chemical stability, assay, pH and macroscopic aspects. Samples were collected after 0 and 21 days to evaluate microbiological stability. It was possible to demonstrate stability for one of the formulations for a 14-day period. Throughout the study, the chosen formulation presented adequate quantification of fluconazole, constant pH, no organoleptic changes and no microbial growth. The results suggest the incorporation of a new formulation for fluconazole to the Farmacia Semi-Industrial portfolio)