Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais

Abstract

OBJECTIVE:To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS:Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fi ctitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identifi cation and quantifi cation tests on compounded capsules. RESULTS:The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specifi cation. The simvastatin content in the capsules was within the specifi cation in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specifi cation in this test. In the dissolution test, eight samples presented unsatisfactory results in the fi rst stage of the test, while the remainder presented inconclusive results. CONCLUSIONS:The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid – an analysis of Cambodian samples

“…The circulation of substandard generic amoxicillin-clavulanic acid was reported in two recent studies in other countries [37,38]. Some reports suggest that different coatings and additives with similar active ingredients are used to make medicines bio-available [39]. Therefore, the low dissolution rate of amoxicillin observed in this study might be due to the additives used in generic formulations.…”

Análise in silico da farmacodinâmica, farmacocinética e toxicidade de dois compostos isolados da Actinidia deliciosa para investigação do seu potencial anti-hiperlipêmico

“…A doença aterosclerótica destaca-se por ser a patogenia que provoca maior mortalidade na sociedade brasileira, sendo essa uma doença multifatorial, que envolve o acúmulo do colesterol e oxidação do mesmo no meio intracelular, gerando elevação da pressão media arterial e agregação plaquetária. A prevenção da arteriosclerose ocorre a princípio por meio da identificação e controle das hiperlipidemias associadas com o uso de hiperlipidêmicos (dentre estes as estatinas), bem como os fatores de riscos provenientes do estilo de vida inadequada, dieta rica em gordura, e sedentarismo (Markman, Rosa, & Koschtschak, 2010). Conforme Xavier, et al, (2013), nas últimas décadas foi obtido notáveis progressos relacionados ao desenvolvimento de hipolipemiantes, com alto potencial para reduzir a Research, Society andDevelopment, v. 9, n. 7, e790974679, 2020 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i7.4679 hipercolesterolemia, propiciando a obtenção de novas metas terapêuticas.…”

“…As estatinas são uma classe farmacológica, que agem inibindo a ação dessa enzima, proporcionando uma redução nos níveis de lipoproteínas de baixa densidade (LDL), dos triglicerídeos e o aumento dos níveis de lipoproteínas de alta densidade (HDL). A sinvastatina é considerada um pró-fármaco, inibidor competitivo e reversível da HMG-CoA redutase, altamente prescrita para o tratamento da arteriosclerose (Markman, Rosa, & Koschtschak, 2010).…”

Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets

“…[10][11][12][13][14][15][16][17][18][19] LC ion-par coupled to UV detector and visible spectrometric method have also been reported. 20,21 Furthermore, LC-MS/MS was employed to identify SIM impurities or degradation products in bulk drug or tablets dosage form.…”

“…Acetonitrile (ACN) widely used in combination with buffer solution in mobile phases, mainly in SIM official monographs of solid dosage forms. 2,11,12,14,15,18,20,22,23,[25][26][27]29 Methanol in a binary mobile phase has been reported for SIM determination in nanoparticles (specific pharmaceutical dosage form) in the concentration range 20-80 mg mL -1 . ACN worldwide shortage has reached a very high cost in the market between years 2008 and 2009.…”