The objective of this research was to develop and validate analytical methods for the amlodipine besylate (ABC) determination in tablets. Simple, accurate and precise spectrophotometric and HPLC methods were validate for ABC determination in samples containing 5.0 and 10.0 mg of ABC / tablet. For the spectrophotometric method, the first dilutions of samples were made in methanol and the consecutive in distilled water. Determination was made at 364.4 nm. Linearity was in the range of 41.0-61.0 IJg/mL and r= 0.9996. The detection and quantitation limits were respectively, 0.54 IJg/mL and 1.80 IJg/mL. Accuracy and precision were respectively, 98.99% and 0.37%. For HPLC analysis, the following conditions were used: a LiChrospher ®1 00 RP-18 Merck® (250 mm x 4,6 mm, 5!-!m) column; methanol: water with 1 % of triethylamine adjusted to pH 5.0 with phosphoric acid (35:65), as mobile phase; a flow rate of 1.0 mL /min; UV detection at 238 nm and temperature of 22 ±1 °C. Retention time was 3.7 min o Linearity was in the range of 50.0-350.0 IJg/mL and r = 0.9999. The detection and quantitation limits were respectively, 2.26 IJg/mL and 7.52 IJg/mL. Accuracy and precision were respectively, 100.18% and 0.37%. Both methods can be used in routine analysis for quality control of tablets containing ABC.
Mesenchymal stem cells (MSCs) are described as undifferentiated cells with high capacity for selfrenewal and differentiation ability in different tissues. MSCs are found in various locations in the adult organism as bone marrow, adipose tissue; and in fetal tissues as umbilical cord, placenta and amniotic fluid. They are able to produce and secrete a number of bioactive molecules with different effects: anti-fibrotic, angiogenic and mitogen. These cells also present a great immunomodulatory and anti-inflammatory potential described in experimental and human models. Several studies have demonstrated the ability of MSCs to suppress the proliferation and activation of T, B and NK cells in vitro and in vivo. Its low immunogenic action causes are not recognized by HLA mismatched receptor complex because they express low levels of MHC-I do not express MHC-II and costimulatory molecules CD40, CD80 and CD86. Because of these unique characteristics, MSCs arouse great interest in possible clinical applications in the therapy of diseases that affect the immune system. Although depending on the tissue microenvironment, the MSCs can also trigger inflammatory events. In this work, we described the main factors and another structures involved in MSCs immunoregulation.
High blood pressure (HBP) is a multifactorial disease that affects millions of people around the world and contributes to a large number of deaths due to acute myocardial infarction, stroke and chronic kidney disease. Its etiology remains inconclusive, but it is known that it arises of central and peripheral catecholaminergic dysfunction. Thus, cellular mechanisms are still under investigation. Its pathophysiology is characterized by an increase in systolic and diastolic blood pressure levels. The national and international guidelines for hypertension indicate that effective pharmacotherapy provides a control in blood pressure values and mortality⁄ morbidityreduction. Classes of antihypertensive drugs available for clinical use are diuretics, beta-blockers, alpha-blockers, sympatholytic, calcium channel antagonists, angiotensin converting enzyme inhibitors and angiotensin receptor antagonists of angiotensin II (ARBs). ARBs (i.e.: candesartan, irbesartan, losartan, olmesartan, telmisartan and valsartan)represent current and often used drug class in Brazil.They have different molecular configurations with independent action mechanismsin angiotensin II AT1 receptor. The objective of this paper is to discuss the pathophysiology and pharmacotherapy of hypertension, emphasizing the antagonists of angiotensin II used in Brazil, since they constitute a class of antihypertensive drugs that has fewer side effects and greater therapeutic efficacy.
Resumo: o estudo de estabilidade acompanha o fármaco desde o seu desenvolvimento até a sua comercialização. A Agência Nacional de Vigilância Sanitária (ANVISA), órgão regulador responsável pelos registros de medicamentos novos no Brasil, exige a apresentação de resultados satisfatórios de estudo de estabilidade para que seja concedido o registro, renovação de registro e também as possíveis alterações pós-registro dos medicamentos. Através deste levantamento bibliográfico foi possível compreender que o estudo de estabilidade, quando realizado de forma correta seguindo as diretrizes das legislações e guias vigentes, estabelece com segurança o prazo de validade dos produtos, sendo também uma importante fonte de informação para possíveis desvios de qualidade. Palavras-chave:Estudo de estabilidade, Registro, Renovação, Pós-registro.Abstract: stability study accompanies the drug from development to commercialization. ANVISA is responsible, in Brazil, for registration of new drugs, requires the submission of satisfactory results of stability study for registration, renewal of registration and the possible post-drug registration changes will be granted. Through this literature survey, it was possible to understand that the study of stability, when properly carried out following the guidelines existing laws and guide establishes with certainty the validity of the products, is also an important source of information for possible deviations in quality.
Abamectin is a drug with antiparasitic properties used in several pharmaceutical formulations. The objective of this research was to develop and validate a high performance liquid chromatographic (HPLC) method for quantification of the two abamectin homologs (H 2 B 1a and H 2 B 1b) in gel formulation. This HPLC method was validated using a LichroCart ® 100 RP-18 (125 x 4 mm, 5 µm) column. The mobile phase contained of acetonitrile and water (95:5 v/v) with 1% acetic acid. The flow rate was 1.0 mL min-1 and UV detection was performed at 245 nm. Mobile phase solutions were prepared containing a nominal concentration 185.2 µg mL-1 H 2 B 1a and 9.6 µg mL-1 H 2 B 1b. The method displayed good linearity in the concentration range of 148.1-222.3 µg mL-1 and 7.7-11.5 µg mL-1 , for H 2 B 1a and H 2 B 1b , respectively, with a correlation coefficient of (r)> 0.99 for both compounds, calculated by the least mean squares method. Detection limits (DLs) were 2.8 µg mL-1 and 1.2 µg mL-1 and quantitation limits (QLs) were 8.6 µg mL-1 and 3.8 µg mL-1 , for H 2 B 1a and H 2 B 1b , respectively. The method is simple, economical and efficient for the quantitative determination of abamectin H 2 B 1a and H 2 B 1b homologs in pharmaceutical preparations. Uniterms: Abamectin homologs/validation method/gel formulation. Abamectin homologs. High Perfomance Liquid Chromatography (HPLC).
Leite, Helen Dutr a L5 3 3 m Mé t o d o s i n d i c a t i v o s d e e s t a b i l i d a d e p a r a d e t e r m i n a ç ã o d o b e s i l a t o d e a n l o d i p i n o , n i f e d i p i n o e n i m o d i p i n o c o n s i d e r a d o s inib id o r es d o canal d e cálcio / Helen Dutra Leite.-São Paulo, 2014. 104p. T ese (d o uto r ad o)-Faculd ad e d e Ciências Farmacêuticas d a Univer sid ad e d e São P aulo. Dep artamento d e Farmácia.
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