In this study a simple and efficient stability-indicating HPLC method with short run time was developed for the determination of nitisinone. The stress degradation of nitisinone was studied in different acidic, basic, oxidative, thermal and photolytic conditions. The chromatographic separation was achieved on a Nova-Pak C18 column using a mixture of 50 mM NaH2PO4 (pH 2.5) and acetonitrile (45:55, v/v) as mobile phase. UV detection was performed at 280 nm. Good linearity was observed over the concentration range of 0.5-50 μg/ml with r(2)>0.999. The within-day and between-day precision values were less than 2%. The proposed method could be used for the determination of nitisinone in the presence of its degradation products and also dosage form excipients for the quality control purposes.
Keywords: HPLC; Nitisinone; UV detection; stability-indicating; stress degradation.