A rapid validated UV-HPLC method for the simultaneous determination of the antiretroviral compounds darunavir and raltegravir in their dosage form.

Autor: Estan-Cerezo G, García-Monsalve A, Soriano-Irigaray L, Rodríguez-Lucena FJ; Francisco José Rodríguez-Lucena, Servicio de Farmacia-Hospital General Universitario de Elche-Fisabio, Elche, Spain. franrolu@gmail.com., Navarro-Ruiz A
Jazyk: angličtina
Zdroj: Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia [Rev Esp Quimioter] 2017 Jun; Vol. 30 (3), pp. 195-200. Date of Electronic Publication: 2017 Mar 29.
Abstrakt: Objective: A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method with ultraviolet detection has been developed for quantification of darunavir and raltegravir in their pharmaceutical dosage form.
Methods: The assay enables the measurement of both drugs with a linear calibration curve (R2= 0.999) over the concentration range 5-100 mg/L. The determination was performed on an analytical Tracer Excel 120 ODSB (15x0.4.6 cm) column at 35ºC. The selected wavelength was 254 nm. The mobile phase was a mixture of 0.037 M sodium dihydrogen phosphate buffer, acetonitrile and methanol (40:50:10, v/v/v) at a flow rate of 2.0 mL/min Nevirapine (50 mg/L) was used as internal standard.
Results: Accuracy, intra-day repeatability (n = 5), and inter-day precision (n = 3) were found to be satisfactory, being the accuracy from -4.33 to 3.88% and precisions were intra-day and inter-day, 0.25% and 4.42% respectively in case of darunavir. Raltegravir intra-day and inter-day precisions lower of 1.01 and 2.36%, respectively and accuracy values bet from -4.02 to 1.06%.
Conclusions: Determination of the darunavir and raltegravir in their dosage form was done with a maximum deviation of 4%. This analytical method is rapid, easily implantable and offers good results.
Databáze: MEDLINE