HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets
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<sup>®</sup> and to its corresponding g...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-04-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/12/4/323 |
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| author | Emanuela Scudellaro Luciana Tartaglione Fabio Varriale Carmela Dell’Aversano Orazio Taglialatela-Scafati |
| author_facet | Emanuela Scudellaro Luciana Tartaglione Fabio Varriale Carmela Dell’Aversano Orazio Taglialatela-Scafati |
| author_sort | Emanuela Scudellaro |
| collection | DOAJ |
| description | 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<sup>®</sup> and to its corresponding generic sapropterin Dipharma (Diterin<sup>®</sup>), 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 <i>T</i> = 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<sup>®</sup> formulation, which was related to a lower increase of some impurities compared to Kuvan<sup>®</sup>. |
| first_indexed | 2024-03-10T20:41:37Z |
| format | Article |
| id | doaj.art-0bb2bf0b301640bda70e66eb84385bfe |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T20:41:37Z |
| publishDate | 2020-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-0bb2bf0b301640bda70e66eb84385bfe2023-11-19T20:35:15ZengMDPI AGPharmaceutics1999-49232020-04-0112432310.3390/pharmaceutics12040323HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic TabletsEmanuela Scudellaro0Luciana Tartaglione1Fabio Varriale2Carmela Dell’Aversano3Orazio Taglialatela-Scafati4Department of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, ItalyDepartment of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, ItalyDepartment of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, ItalyDepartment of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, ItalyDepartment of Pharmacy, School of Medicine and Surgery, Universita’ degli Studi di Napoli Federico II, Via D. Montesano, 49, 80131 Naples, ItalyThis 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<sup>®</sup> and to its corresponding generic sapropterin Dipharma (Diterin<sup>®</sup>), 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 <i>T</i> = 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<sup>®</sup> formulation, which was related to a lower increase of some impurities compared to Kuvan<sup>®</sup>.https://www.mdpi.com/1999-4923/12/4/323sapropterinPKUBH<sub>4</sub> deficiencychemical contentimpurity identificationHPLC-UV |
| spellingShingle | Emanuela Scudellaro Luciana Tartaglione Fabio Varriale Carmela Dell’Aversano Orazio Taglialatela-Scafati HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets Pharmaceutics sapropterin PKU BH<sub>4</sub> deficiency chemical content impurity identification HPLC-UV |
| title | HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets |
| title_full | HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets |
| title_fullStr | HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets |
| title_full_unstemmed | HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets |
| title_short | HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets |
| title_sort | hplc based analysis of impurities in sapropterin branded and generic tablets |
| topic | sapropterin PKU BH<sub>4</sub> deficiency chemical content impurity identification HPLC-UV |
| url | https://www.mdpi.com/1999-4923/12/4/323 |
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