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®.
2020
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]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/813661
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