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Ultraviolet spectrophotometric method for analytical determination of mianserin hydrochloride in coated tablets and comparison with LC
Sfair, Letícia Lenz; Graeff, Jeferson Scarpari; Steppe, Martin; Schapoval, Elfrides Eva Scherman.
  • Sfair, Letícia Lenz; Federal University of Rio Grande do Sul. Faculty of Pharmacy. Department of Production and Drug Quality Control. BR
  • Graeff, Jeferson Scarpari; Federal University of Rio Grande do Sul. Faculty of Pharmacy. Department of Production and Drug Quality Control. BR
  • Steppe, Martin; Federal University of Rio Grande do Sul. Faculty of Pharmacy. Department of Production and Drug Quality Control. BR
  • Schapoval, Elfrides Eva Scherman; Federal University of Rio Grande do Sul. Faculty of Pharmacy. Department of Production and Drug Quality Control. BR
Braz. j. pharm. sci ; 51(4): 833-837, Oct.-Dec. 2015. tab, graf
Article in English | LILACS | ID: lil-778419
ABSTRACT
abstract Ultraviolet spectrophotometric (UV) and Liquid Chromatographic (LC) methods for the determination of mianserin hydrochloride in pharmaceutical formulation were developed and validated. The various parameters, such as specificity, linearity, precision and accuracy were studied according to International Conference on Harmonization (ICH, 2005). For UV method, mianserin hydrochloride was determinate at 278 nm using HCl 0.1 M as the solvent. The response was linear in the concentration range of 20.0 - 140.0 µg/mL (r = 0.9998). Precision data evaluated by relative standard deviation was lower than 2%. The UV method was simple, rapid and low cost. Chromatographic analyses were performed in an Ace C18 column and the mobile phase was composed of methanol, 50 mM monobasic potassium phosphate buffer and 0.3% triethylamine solution adjusted to pH 7.0 with phosphoric acid 10% (8515). LC method was specific, linear, precise, exact and robust. The results confirmed that the both methods are valid and useful to the routine quality control of mianserin hydrochloride in coated tablets. Statistical analysis by Student´s t-test showed no significant difference between the results obtained by UV and LC methods.
RESUMO
resumo Os métodos por espectrofotometria na região do ultravioleta (UV) e por cromatografia líquida (CL) para determinação do cloridrato de mianserina na forma farmacêutica foram desenvolvidos e validados. Os vários parâmetros, como especificidade, linearidade, precisão e exatidão foram avaliados de acordo com o International Conference on Harmonization (ICH, 2005). Para o método de UV, o cloridrato de mianserina foi determinado utilizando o comprimento de onda de 278 nm e HCl 0,1 M como solvente. A resposta foi linear na faixa de concentração de 20,0 a 140,0 µg/Ml (r = 0,9998). A precisão foi avaliada pelo valor de desvio padrão relativo (DPR) inferior a 2%. O método por UV é simples, rápido e de baixo custo. As análises cromatográficas foram realizadas em uma coluna Ace C18 e a fase móvel foi composta por metanol, tampão fosfato de potássio monobásico 50 mM com 0,3% de trietilamina com o pH ajustado para 7,0 com ácido fosfórico 10% (8515). O método de CL foi específico, linear, preciso, exato e robusto. Os resultados confirmam que ambos os métodos são válidos e úteis para o controle de qualidade do cloridrato de mianserina em comprimidos revestidos. A análise estatística por teste t de Student não mostrou diferença significativa entre os resultados obtidos para os métodos de UV e CL.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Spectrophotometry, Ultraviolet / Mianserin Type of study: Diagnostic study / Evaluation studies Language: English Journal: Braz. j. pharm. sci Year: 2015 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Rio Grande do Sul/BR

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Full text: Available Index: LILACS (Americas) Main subject: Spectrophotometry, Ultraviolet / Mianserin Type of study: Diagnostic study / Evaluation studies Language: English Journal: Braz. j. pharm. sci Year: 2015 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Rio Grande do Sul/BR