Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination
An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method...
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| Format: | Article |
| Language: | English |
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Sciendo
2019-09-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.2478/acph-2019-0025 |
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| _version_ | 1832574164083408896 |
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| author | Peterka Tanja Rozman Lušin Tina Trdan Bergles Jure Ham Zoran Grahek Rok Urleb Uroš |
| author_facet | Peterka Tanja Rozman Lušin Tina Trdan Bergles Jure Ham Zoran Grahek Rok Urleb Uroš |
| author_sort | Peterka Tanja Rozman |
| collection | DOAJ |
| description | An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method was applied to analyses of commercial samples and was validated in terms of linearity, precision, accuracy, sensitivity and specificity. It was found to be linear, precise and accurate in the range of 0.05 to 0.6 % of the impurities level in pharmaceutical dosage forms. Stability indicating power of the method was demonstrated by the results of forced degradation studies. The forced degradation study in solution revealed tacrolimus instability under stress alkaline, thermal, light and photolytic conditions and in the presence of a radical initiator or metal ions. The drug was stable at pH 3–5. Solid-state degradation studies conducted on amorphous tacrolimus demonstrated its sensitivity to light, elevated temperature, humidity and oxidation. |
| format | Article |
| id | doaj-art-54ec73a7ee72486f86dd35defad533fe |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-54ec73a7ee72486f86dd35defad533fe2025-02-02T00:31:54ZengSciendoActa Pharmaceutica1846-95582019-09-0169336338010.2478/acph-2019-0025acph-2019-0025Forced degradation of tacrolimus and the development of a UHPLC method for impurities determinationPeterka Tanja Rozman0Lušin Tina Trdan1Bergles Jure2Ham Zoran3Grahek Rok4Urleb Uroš5Lek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaLek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaLek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaLek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaLek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaLek Pharmaceticals d.d.SI-1526Ljubljana, SloveniaAn ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method was applied to analyses of commercial samples and was validated in terms of linearity, precision, accuracy, sensitivity and specificity. It was found to be linear, precise and accurate in the range of 0.05 to 0.6 % of the impurities level in pharmaceutical dosage forms. Stability indicating power of the method was demonstrated by the results of forced degradation studies. The forced degradation study in solution revealed tacrolimus instability under stress alkaline, thermal, light and photolytic conditions and in the presence of a radical initiator or metal ions. The drug was stable at pH 3–5. Solid-state degradation studies conducted on amorphous tacrolimus demonstrated its sensitivity to light, elevated temperature, humidity and oxidation.https://doi.org/10.2478/acph-2019-0025tacrolimusforced degradationuhplcimpuritiesstability |
| spellingShingle | Peterka Tanja Rozman Lušin Tina Trdan Bergles Jure Ham Zoran Grahek Rok Urleb Uroš Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination Acta Pharmaceutica tacrolimus forced degradation uhplc impurities stability |
| title | Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination |
| title_full | Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination |
| title_fullStr | Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination |
| title_full_unstemmed | Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination |
| title_short | Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination |
| title_sort | forced degradation of tacrolimus and the development of a uhplc method for impurities determination |
| topic | tacrolimus forced degradation uhplc impurities stability |
| url | https://doi.org/10.2478/acph-2019-0025 |
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