This work was aimed at the definition of a chromatographic method able to separate and quantify impurities present in sapropterin-containing drugs during an accelerated stability study. The chromatographic method was applied to the orphan drug Kuvan® and to its corresponding generic sapropterin Dipharma (Diterin®), both of which are approved for the treatment of hyperphenylalaninemia-induced symptoms. The two products tested had a similar manufacture date and both had an approved stability shelf-life of three years. Samples were analyzed by HPLC at T = 0 and after six months of storage at 40 °C and 75% relative humidity. Identification of the impurities was supported by a detailed mass spectrometry and MS/MS profile. The analysis demonstrated an overall higher stability for the Diterin® formulation, which was related to a lower increase of some impurities compared to Kuvan®.
HPLC-based analysis of impurities in sapropterin branded and generic tablets / Scudellaro, E.; Tartaglione, L.; Varriale, F.; Dell'Aversano, C.; Taglialatela-Scafati, O.. - In: PHARMACEUTICS. - ISSN 1999-4923. - 12:4(2020), p. 323. [10.3390/pharmaceutics12040323]
HPLC-based analysis of impurities in sapropterin branded and generic tablets
Scudellaro E.Membro del Collaboration Group
;Tartaglione L.Membro del Collaboration Group
;Varriale F.Membro del Collaboration Group
;Dell'aversano C.Conceptualization
;Taglialatela-Scafati O.
Ultimo
2020
Abstract
This work was aimed at the definition of a chromatographic method able to separate and quantify impurities present in sapropterin-containing drugs during an accelerated stability study. The chromatographic method was applied to the orphan drug Kuvan® and to its corresponding generic sapropterin Dipharma (Diterin®), both of which are approved for the treatment of hyperphenylalaninemia-induced symptoms. The two products tested had a similar manufacture date and both had an approved stability shelf-life of three years. Samples were analyzed by HPLC at T = 0 and after six months of storage at 40 °C and 75% relative humidity. Identification of the impurities was supported by a detailed mass spectrometry and MS/MS profile. The analysis demonstrated an overall higher stability for the Diterin® formulation, which was related to a lower increase of some impurities compared to Kuvan®.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
