Validation of an analysis method for 4-amino-3-hydroxybutyric acid by reversed-phase liquid chromatography

A rapid and simple reversed-phase liquid chromatographic method that did no t require the derivatization of 4-amino-3-hydroxybutyric acid (GABOB) was d eveloped and validated. The method proved to be suitable for the determinat ion of GABOB concentrations in finished pharmaceutical product (tablets). T he method was developed using a RP-18 column, UV detection at 210 nm and 0. 01 M sodium heptasulphonate solution, at pH 2.4, as the mobile phase. Diffe rent validation parameters were included and satisfactorily evaluated. The specificity of the method was demonstrated. Linearity was established in th e range 0.40-0.60 mg/ml (r = 0.997). The method showed excellent accuracy ( 100.1%). Precision (repeatability) gave a relative standard deviation value of 0.68%, while the intermediate precision was 1.70%. A robustness test sh owing the influence of different pH values and counter-ion concentrations w as also performed. (C) 2000 Elsevier Science B.V. All rights reserved.