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Ann Pharm Fr ; 77(5): 418-425, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31296331

RESUMEN

Cyclobenzaprine hydrochloride, a skeletal muscle relaxant has been determined using an ecofriendly micellar HPLC method in its pure form and tablets. The chromatographic determination was performed using C8 monolithic column (100mm×4.6mm i.d., 5µm particle size) and micellar eluent which was composed of sodium dodecyl sulfate (0.15M), n-propanol (15%), 0.02M orthophosphoric acid (pH 4.5) and 0.3% triethylamine using UV detection of effluent was set at 225nm. The calibration plot showed good linearity over concentration range from 2-40µg/mL. The assay results were statistically validated for linearity, accuracy, precision and specificity according to ICH guidelines. Additionally, regarding USP guidelines, the uniformity of tablets content and in-vitro dissolution test of the tablets was tested using the proposed method. Simple and rapid applicability of the developed method allowed determination of the drug in its pure and tablet dosage forms. Moreover, the major advantage of micellar HPLC technique is to determine the drug in biological fluids without prior extraction steps. Depending on this, the estimation of cyclobenzaprine in spiked human urine was so simple without traditional tedious procedures. The proposed method offers the advantages of sensitivity and simplicity in addition to short analysis time which didn't exceed 6 minutes.


Asunto(s)
Amitriptilina/análogos & derivados , Tecnología Química Verde/métodos , Relajantes Musculares Centrales/análisis , Amitriptilina/análisis , Amitriptilina/orina , Cromatografía Líquida de Alta Presión , Jugo Gástrico/química , Guías como Asunto , Humanos , Límite de Detección , Micelas , Relajantes Musculares Centrales/orina , Estándares de Referencia , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Solubilidad , Espectrofotometría Ultravioleta , Comprimidos/análisis
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