Validation of UV-Visible and HPLC method for the determination of sodium p-aminosalicylate and m-aminophenol in a new pharmaceutical formulation

HERGERT LY; RAVETTI S; MAZZIERI MR

INTERNATIONAL JOURNAL OF PHARMACEUTICAL COMPOUNDING

International Journal of Pharmaceutical Compounding (IJPC)

Año: 2016 vol. 20 p. 63 - 70

1516-5140

Sodium 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 highly sensitive, precise and accurate and can be used for the reliable quantification of sodium p-aminosalycilate in the new alternative formulation. HPLC approach demonstrated to be stability-indicating method therefore is suitable for the investigation of the chemical stability of sodium p-aminosalycilate.