Desenvolvimento e validação de método analítico para a determinação de sulfassalazina em suspensão oral: comparação do método espectrofotométrico e de cromatografia líquida de alta eficiência (CLAE)

Costa, Mayre Aparecida Borges da; Ricci-Júnior, Eduardo; Santos, Elisabete Pereira dos; Mansur, Cláudia R. E.; Campos, Vânia Emerich Bucco

doi:10.1590/s0100-40422012000400028

Cited by 4 publications

(4 citation statements)

References 10 publications

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“…This technique is highlighted in the scientific literature, in which several reports are focused in drug quantitation with a performance equivalent to HPLC, i.e. assaying fluoxetine (15), sulfasalazine (16), paliperidone (17) and posaconazole (18). In these studies, there is no significant difference between the results obtained by both techniques.…”

Section: Resultsmentioning

confidence: 99%

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

Barbosa¹,

Rodrigues²,

Volpato³

et al. 2017

Drug Anal. Res.

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UV spectrophotometry is an analytical technique used routinely for qualitative and quantitative assay due the low cost and reliability during analysis. In this work, it was validated a quantitative UV method for determination of agomelatine in coated tablets. The parameters specificity, linearity, precision, accuracy and robustness were evaluated according to official guidelines. Methanol was selected as solvent and the maximum wavelength for drug analysis was 230 nm. The purposed assay showed to be specific and the linearity was proved in a range of 0.5 - 2.5 µg/mL. The RSD values obtained during precision assay (inter-day RSD = 1.75%) indicated the method reproducibility, and the accuracy testing showed good results from recovery test. Robustness assay was complementary and showed that the purposed method is adequate for drug quantitation in commercial samples, being a reliable alternative to chromatographic assay.

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Section: Resultsmentioning

confidence: 99%

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

Barbosa¹,

Rodrigues²,

Volpato³

et al. 2017

Drug Anal. Res.

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“…12,15,29,30,32 Este parâmetro foi mensurado por meio de análises estatísticas de variância, obtendo-se resultados significativos para a regressão linear e não significativos para o desvio da linearidade (p < 0,05). O coeficiente de correlação encontrado para a curva média foi de 0,9999 (Tabela 1).…”

Section: Validação Do Método Analítico Por Espectrofotometria Na Regiunclassified

Desenvolvimento e validação de um método analítico por espectrofotometria UV para quantificação de carvedilol

Borba¹,

Riekes²,

Pereira³

et al. 2013

Quím. Nova

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Recebido em 5/7/12; aceito em 22/10/12; publicado na web em 20/2/13 DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC METHOD TO QUANTIFY CARVEDILOL. This paper reports the development and validation of a new analytical method using UV spectrophotometry to quantify carvedilol (CRV) in hydrophilic matrices and raw material. This method was shown to be linear, accurate, precise, robust and to have adequate limits of quantification and detection (LQ and LD, respectively), allowing its use in the dissolution test of hydrophilic matrices. The content of CRV determined through this method was compared with two previously validated methods based on the reference techniques of High Performance Liquid Chromatography (HPLC) and Potentiometric Titrations (PT). ANOVA confirmed the equivalence of these methods, showing no significant differences.Keywords: carvedilol; UV spectrophotometry; validation. INTRODUÇÃOA hipertensão arterial é considerada um importante problema de saúde e uma das principais causas de morbidade e mortalidade na maioria dos países desenvolvidos do mundo. 1,2 Sua prevalência mundial é de aproximadamente 30%, sendo considerada um importante fator de risco para o acidente vascular cerebral, doença cardíaca isquê-mica e insuficiência cardíaca. Neste contexto, a hipertensão arterial representa um elevado custo econômico-social sobre os sistemas de saúde, famílias e sociedade como um todo. 2 O carvedilol (CRV), Figura 1, é um agente hipotensor antagonista não seletivo dos receptores β-adrenérgicos, que promove a diminuição da resistência vascular periférica através do bloqueio dos receptores adrenérgicos α1. 3,4 É amplamente utilizado no tratamento da hipertensão arterial sistêmica e controle de doenças cardiovasculares associadas, no intuito de reduzir a mortalidade cardiovascular em pacientes vítimas de infarto do miocárdio, a insuficiência cardíaca e a disfunção ventricular esquerda. 5,6 O CRV apresenta-se na forma de pó cristalino de coloração branca ou quase branca e é caracterizado como uma base fraca praticamente insolúvel em água, com tempo de meia-vida de 6-10 h, requerendo duas administrações diárias. 7-9 Dessa forma, este fármaco possui baixa biodisponibilidade (em torno de 25%) e significante metabolismo de primeira passagem. 7-9 Tais características biofarmacêuticas tornam o CRV alvo de pesquisas e desenvolvimento de sistemas de liberação modificada, como os comprimidos de matrizes hidrofílicas. 10 A quantificação de um fármaco em uma formulação e na sua forma isolada representa um aspecto fundamental da garantia da qualidade de medicamentos. 11 O desenvolvimento e a validação de métodos analíticos têm como objetivo verificar se o fármaco se apresenta apropriado para a finalidade a que se destina e se esta é capaz de fornecer resultados confiáveis, que possam ser satisfatoriamente interpretados. 12,13 A monografia oficial para o doseamento de CRV encontra-se descrita na Farmacopeia Britânica, 14 contudo esta se aplica apenas à matéria-prima e se dá através da técnica titulométrica. As Farmaco...

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“…A high performance liquid chromatography (HPLC) method for the determination of simvastatin nanocapsules was developed and validated by Lorenzoni 2019. However, according to Costa et al (2012), HPLC methods may demand extensive use of reagents for the determination of medicines, thereby generating large amounts of waste and becoming more dangerous for the environment (12,13). Therefore, it is desirable for the development of fast and accurate method with reduced production of residues for analysis of drugs and medicines.…”

Section: Introductionmentioning

confidence: 99%

Second-derivative spectrophotometry for the analysis of simvastatin in polymeric nanocapsules

Gomes¹,

Negretto²,

Naisinger³

et al. 2019

Drug Anal. Res.

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Conventional spectrophotometry methods are very susceptible to the presence of interferences in complex mixtures such as nanoparticules, requiring prior treatment or extraction of the analyte, and not always providing an adequate response. Derivative spectrophotometry method is capable to eliminate its interference; it is an alternative method for drugs determination in complex matrices. This work investigated the utility of derivate spectrophotometry in assay of simvastatin in polymeric nanocapsules (SIVNC). Shimadzu® UV-1650 double-beam spectrophotometer with 1.0 cm quartz cells was used in this study. The second-order derivative spectrum was obtained employing Δλ=20,000 nm and scaling factor=9.0. The determinations were made at 239 nm (2D239) by zero-crossing method. 2D239 method was validated employing the parameters: specificity, linearity, robustness, precision and accuracy. Results: The specificity test showed there was no interference of constituents commonly found in SIVNC formulation in 2D239. The standard curve showed a correlation coefficient of 0.994. The robustness was evaluated by small changes in the conditions of sample analysis and however, no significant changes were observed regarding drug quantitation. The precision was demonstrated by relative standard deviation (RSD) of intra-day (RSD=1.61-3.76) and inter-day studies (RSD=2.32). The recovery test resulted in an average of 100.66%, which confirmed the accuracy of the method. The procedure was simple and rapid; therefore this technique offers an alternative for determination of SIVNC without interferences.

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Desenvolvimento e validação de método analítico para a determinação de sulfassalazina em suspensão oral: comparação do método espectrofotométrico e de cromatografia líquida de alta eficiência (CLAE)

Cited by 4 publications

References 10 publications

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

Desenvolvimento e validação de um método analítico por espectrofotometria UV para quantificação de carvedilol

Second-derivative spectrophotometry for the analysis of simvastatin in polymeric nanocapsules

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