Ultraviolet spectrophotometric method for analytical determination of mianserin hydrochloride in coated tablets and comparison with LC

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 C 18 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% (85:15). 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. Uniterms:Ultraviolet spectrophotometry/qualitative analysis. Liquid chromatographic/qualitative analysis. Mianserin hydrochloride/determination in tablets. Coated tablets/qualitative analysis.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 C 18 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% (85:15). 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.Unitermos: Espectrofotometria na região do ultravioleta/análise quantitativa. Cromatografia líquida/ análise quantitativa. Cloridrato de mianserina/determinação em comprimidos. Comprimidos revestidos/ análise qualitativa.

Determination of Mianserin Using Tropaeolin-Ooo by Ion Pair Formation

“…Those methods include usage of both UV and visible spectrophotometric [6][7][8][9], HPLC [10][11][12][13], capillary gas chromatography and electrophoresis [14][15][16][17] and Gas chromatography [18][19]. In UV spectrophotometric method proposed by S fair et al [6], linearity was tested in the range of 20.0-140.0 μg/ml and continued study by liquid chromatographic method in which an Ace C18 column was used along with the mobile phase comprising of methanol and KH2PO4 buffer (pH 7.0) in the ratio of 85:15 v/v. Farag et al [7] developed an extractive colorimetric method using four dyes where pH has to be maintained carefully using buffer solutions.…”

Determination of Mianserine using Fe3+-phenanthroline by visible Spectrophotometry

“…Brain nerve cells are influenced by this drug [1][2]. Spectrophotometric [3][4][5][6], HPLC [7][8][9][10], capillary electrophoresis [11][12][13][14] and gas chromatographic methods [15][16] were used for quantitative determination of Mianserin in their formulation forms. Taking into consideration of high cost of the instruments used by researchers in these methods, phenanthroline is proposed as a chromogen in the present study.…”