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Ultraviolet spectrophotometric method for analytical determination of mianserin hydrochloride in coated tablets and comparison with LC BJPS
Sfair,Letícia Lenz; Graeff,Jeferson Scarpari; Steppe,Martin; Schapoval,Elfrides Eva Scherman.
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,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Ultraviolet spectrophotometry/qualitative analysis; Liquid chromatographic/qualitative analysis; Mianserin hydrochloride/determination in tablets; Coated tablets/qualitative analysis..
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400833
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Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method BJPS
Martins,Magda Targa; Paim,Clésio Soldatelli; Steppe,Martin.
A dissolution test for tablets containing 100 mg of lamotrigine was developed and validated. The dissolution test was applied to compare the dissolution profile of Neural® with the reference product Lamictal®. The analysis procedure was carried out using a simple ultraviolet method at 267 nm. After the determination of solubility and sink conditions, the parameters selected were paddles at 50 rpm, 900 mL of 0.01 M hydrochloric acid, and 30 minutes duration (single point). This method was validated for specificity, linearity, accuracy, precision and robustness. Lamotrigine stability was also evaluated in dissolution medium.
Tipo: Info:eu-repo/semantics/article Palavras-chave: Lamotrigine; Dissolution test/validation; Medicines/quality control.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200003
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