RESUMO
During preformulation studies of cosmetic/pharmaceutical products, thermal analysis techniques are very useful to detect physical or chemical incompatibilities between the active and the excipients of interest that might interfere with safety and/or efficacy of the final product. Differential scanning calorimetry (DSC) was used as a screening technique for assessing the compatibility of avobenzone with some currently used cosmetic excipients. In the first phase of the study, DSC was used as a tool to detect any interaction. Based on the DSC results alone, cetearyl alcohol, isopropyl myristate, propylparaben, diethylhexyl syringylidene malonate, caprylic capric triglyceride, butylated hydroxytoluene (BHT), glycerin, cetearyl alcohol/ceteareth 20, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, and paraffinum liquidum exhibit interaction with avobenzone. Stressed binary mixtures (stored at 50°C for 15 days) of avobenzone and excipients were evaluated by high-performance liquid chromatography. Binary mixtures were further investigated by infrared (IR) spectroscopy. Based on DSC, isothermal stress testing, and fourier transform infrared results; avobenzone is incompatible with caprylic capric triglyceride, propylparaben, and BHT.
Assuntos
Hidroxitolueno Butilado/química , Caprilatos/química , Excipientes/química , Parabenos/química , Propiofenonas/química , Protetores Solares/química , Varredura Diferencial de Calorimetria , Cromatografia Líquida de Alta Pressão , Incompatibilidade de Medicamentos , Estabilidade de Medicamentos , Humanos , Espectroscopia de Infravermelho com Transformada de Fourier , Temperatura , Triglicerídeos/químicaRESUMO
An isocratic HPLC method was developed and validated for the quantitation of methocarbamol in the presence of its degradation products. Quantitation was achieved using a reversed-phase C18 column at ambient temperature with mobile phase consisting of methanol-water-tetrahydrofuran (25 + 65 + 10, v/v). The flow rate was 0.9 mL/min. The detection was by UV light at 274 nm. The proposed method was validated for selectivity, precision, linearity, and accuracy. The assay method was found to be linear from 159.0 to 793.2 microg/mL (3.2 to 15.9 microg injected). All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of methocarbamol in a veterinary injection.
Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Metocarbamol/análise , Drogas Veterinárias/análise , Técnicas de Química Analítica/métodos , Química Farmacêutica/métodos , Furanos/análise , Metanol/química , Modelos Químicos , Relaxantes Musculares Centrais/análise , Reprodutibilidade dos Testes , Raios Ultravioleta , Água/químicaRESUMO
An accurate, simple, reproducible, and sensible liquid chromatographic method was developed and validated for the determination of chlorpheniramine maleate and dexamethasone in a tablet formulation. The analysis was performed at room temperature on a reversed-phase C18 column with UV detection at 254 nm. The mobile phase consisted of 7.5 mM monobasic potassium phosphate in methanol-water (62.5 + 37.5) at a constant flow rate of 1 mL/min. The method was validated in terms of linearity, precision, accuracy, and specificity by forced decomposition of chlorpheniramine maleate and dexamethasone initiated by using acid, base, water, hydrogen peroxide, heat, and light. The response was linear in the ranges of 0.04-0.12 and 0.006-0.016 mg/mL for chlorpheniramine maleate (r2 = 0.9999) and dexamethasone (r2 = 0.9994), respectively. The relative standard deviation values for intra- and interday precision studies were 2.39 and 2.02, respectively, for chlorpheniramine maleate and 2.39 and 1.25, respectively, for dexamethasone. Recoveries ranged from 95.07 to 101.95% for chlorpheniramine maleate and from 97.75 to 102.10% for dexamethasone.