Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products
ABSTRACT Multifunctional drug anisomycin was subjected to forced degradation in accordance with International Conference on Harmonisation (ICH) guidelines for the first time. The drug was exposed to the recommended stress conditions of hydrolysis (acidic, alkaline and neutral), oxidation, thermal st...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Universidade de São Paulo
2018-07-01
|
| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200607&lng=en&tlng=en |
| _version_ | 1818755890206998528 |
|---|---|
| author | Ljiljana Tolić Svetlana Grujić Mila Laušević |
| author_facet | Ljiljana Tolić Svetlana Grujić Mila Laušević |
| author_sort | Ljiljana Tolić |
| collection | DOAJ |
| description | ABSTRACT Multifunctional drug anisomycin was subjected to forced degradation in accordance with International Conference on Harmonisation (ICH) guidelines for the first time. The drug was exposed to the recommended stress conditions of hydrolysis (acidic, alkaline and neutral), oxidation, thermal stress and photolysis, in order to investigate its stability. Optimized LC-MS/MS method was validated as recommended by ICH Q2(R1) guideline with respect to the specificity, accuracy, precision, limits of detection and quantitation, linearity and robustness. Anisomycin exhibited high instability under alkaline and thermal (neutral hydrolysis) conditions. It showed moderate stability under acidic, neutral, oxidative, thermal (acidic hydrolysis) and photolytic conditions, with the lowest degradation level observed in the case of light and oxidation stress. Formation of the same degradation product, identified as deacetylanisomycin, was observed under all applied stress conditions. |
| first_indexed | 2024-12-18T05:46:20Z |
| format | Article |
| id | doaj.art-b69069dda4084d2c8e9c9d299eb0c979 |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-18T05:46:20Z |
| publishDate | 2018-07-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-b69069dda4084d2c8e9c9d299eb0c9792022-12-21T21:19:02ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902018-07-0154210.1590/s2175-97902018000217491S1984-82502018000200607Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation productsLjiljana TolićSvetlana GrujićMila LauševićABSTRACT Multifunctional drug anisomycin was subjected to forced degradation in accordance with International Conference on Harmonisation (ICH) guidelines for the first time. The drug was exposed to the recommended stress conditions of hydrolysis (acidic, alkaline and neutral), oxidation, thermal stress and photolysis, in order to investigate its stability. Optimized LC-MS/MS method was validated as recommended by ICH Q2(R1) guideline with respect to the specificity, accuracy, precision, limits of detection and quantitation, linearity and robustness. Anisomycin exhibited high instability under alkaline and thermal (neutral hydrolysis) conditions. It showed moderate stability under acidic, neutral, oxidative, thermal (acidic hydrolysis) and photolytic conditions, with the lowest degradation level observed in the case of light and oxidation stress. Formation of the same degradation product, identified as deacetylanisomycin, was observed under all applied stress conditions.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200607&lng=en&tlng=enAnisomycin/forced degradationStability-indicatingLC-MS/MS/validationDeacetylanisomycin |
| spellingShingle | Ljiljana Tolić Svetlana Grujić Mila Laušević Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products Brazilian Journal of Pharmaceutical Sciences Anisomycin/forced degradation Stability-indicating LC-MS/MS/validation Deacetylanisomycin |
| title | Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products |
| title_full | Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products |
| title_fullStr | Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products |
| title_full_unstemmed | Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products |
| title_short | Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products |
| title_sort | development and validation of a stability indicating lc uv and lc ms ms methods for quantitative analysis of anisomycin and identification of degradation products |
| topic | Anisomycin/forced degradation Stability-indicating LC-MS/MS/validation Deacetylanisomycin |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200607&lng=en&tlng=en |
| work_keys_str_mv | AT ljiljanatolic developmentandvalidationofastabilityindicatinglcuvandlcmsmsmethodsforquantitativeanalysisofanisomycinandidentificationofdegradationproducts AT svetlanagrujic developmentandvalidationofastabilityindicatinglcuvandlcmsmsmethodsforquantitativeanalysisofanisomycinandidentificationofdegradationproducts AT milalausevic developmentandvalidationofastabilityindicatinglcuvandlcmsmsmethodsforquantitativeanalysisofanisomycinandidentificationofdegradationproducts |