Development and validation of an analytical method for the quantification of sulfadiazine in extemporaneous liquid formulations
Sulfadiazine. Analytical method. Validation. Ultra Performance Liquid Chromatography.
Sulfadiazine (SDZ) is one of the drugs used in the treatment of congenital toxoplasmosis, however it is marketed only in the solid pharmaceutical form of tablets and the transformation of the pharmaceutical form has been the strategy adopted to enable the preparation of liquid dosage forms from the tablets. The objective of this study was to validate an analytical methodology to quantify the SDZ in liquid formulations extemporaneous by Ultra Performance Liquid Chromatography (UPLC). The separation was conducted on a Zorbax Extend C18 column, with dimensions of 50 x 2.1 mm (Agilent). The isocratic mobile phase was composed of 1% (v / v) glacial acetic acid (A) and acetonitrile (B) (87:13, v/v). The flow rate was 0.2 mL·min-1 with a running time of 2.4 minutes. SDZ detection was performed at 266 nm using a diode array detector. The method proved to be linear with correlation coefficient equal to 0.9941. It presented limits of detection and quantification of 1,188 μg·mL-1 and 3,601 μg·mL-1, respectively. Recoveries between 99.7% and 100.8% were obtained in accuracy tests and the relative standard deviation of precision was below 5%. Thus, the method is suitable for routine quality control analyzes of SDZ in extemporaneous liquid formulations.