ABSTRACT
OBJECTIVES: A simple, rapid, specific, and highly sensitive ecofriendly spectrofluorimetric method has been developed for the quantification of praziquantel. MATERIALS AND METHODS: A linear relationship was found between fluorescence intensity and praziquantel concentration in the range of 1-20 µg/mL in water at emission wavelength of 286 nm after excitation wavelength at 263 nm with a good correlation coefficient (0.999). RESULTS: The proposed method was validated according to International Conference on Harmonization guidelines and statistical analysis of the results revealed high accuracy and good precision with the percentage relative standard deviation values less than 2. The detection and quantification limits were 0.27 and 0.81 µg/mL, respectively. The proposed method was extended to investigate the stability of the drug and its degradation kinetics in the presence of acidic, alkaline, and oxidative conditions. CONCLUSION: The method was utilized for in vitro dissolution studies of praziquantel tablet formulation. The suggested procedures could be used for the assessment of praziquantel in drug substance and drug products as well as in the presence of its degradation products.
ABSTRACT
ABSTRACT The present work describes the development of a new high performance liquid chromatographic (HPLC) method for the determination of Cefixime trihydrate under different stress conditons as specified by ICH. For the analysis, a Phenomenex (250 x 4.6 mm, 5 µm particle size) ODS column and a SPD 20 A UV detector at 289 nm was used. The selected mobile phase was 10 mM disodium hydrogen phosphate (with 0.5% TEA, pH adjusted to 6.3 with OPA) and methanol in the ratio of 75:25 (v/v) in isocratic mode at a flow rate of 1 mL.min-1.The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9997 in the concentration range of 5-100 μg.mL-1. The stress degradation was performed using acid, alkali, water, hydrogen peroxide and uv light.
RESUMO O presente trabalho descreve o desenvolvimento de um novo alta performance cromatografia líquida (HPLC) método para a determinação de cefixima tri-estresse sob diferentes condições, conforme especificado pelo ICH. Para a análise, a Phenomenex (250 x 4,6 mm, 5 µm de granulometria) ODS coluna e a SPD 20 um detector de UV em 289 nm foi utilizado. A fase móvel selecionado foi de 10 mM hidrogenofosfato dissódico (com 0,5% TEA, o pH ajustado para 6,3 com OPA) e de metanol em razão de 75:25 (v/v) no modo isocrático com uma taxa de fluxo de 1 mL.min-1. A análise de regressão linear para dados da calibração parcelas apresentaram boa relação linear com r2 = 0,9997 no intervalo de concentração de cerca de 5 100 µg.mL-1. Degradação do estresse foi realizado utilizando um ácido, alcalino, a água, o peróxido de hidrogênio e luz uv.
