Validation of Ultraviolet-visible and High-performance Liquid Chromatographic Methods for the Determination of Sodium P-Aminosalicylate and M-Aminophenol in a New Pharmaceutical Formulation

L.Y. HERGERT; S. RAVETTI; M. R. MAZZIERI

Int J Pharm Compd

College of Pharmacy - University of Florida

Año: 2016 vol. 20 p. 63 - 63

1092-4221

odium p-aminosalycilate is an orphan drug used in patients affected with Multidrug-resistant Tuberculosis. Two methods, high-performance liquid chromatographic and UV spectrophotometric for the quantitative determination of sodium p-aminosalycilate and its degradation product m-aminophenol in a new pharmaceutical formulation, powder for extemporaneous reconstitution, were developed in the present work. The parameters linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantification were also studied. Chromatography was carried out by reverse-phase technique on an RP-18 column with a mobile phase composed of 50 mM monobasic/dibasic phosphate buffer and methanol (42.5:42.5:15 v/v/v) with 1.9g of hidroxytetrabutylammonium ionic pare adjusted to pH 7.0 with orthophosphoric acid. The UV spectrophotometric method was performed at 254 nm and 280 nm for quantification of sodium p-aminosalycilate and m-aminophenol, respectively. The proposed methods are hi