Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products
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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, thennal 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.
Keywords:
Anisomycin/forced degradation / Stability-indicating / LC-MS/MS/validation / DeacetylanisomycinSource:
Brazilian Journal of Pharmaceutical Sciences, 2018, 54, 2Publisher:
- University of Sao Paulo, Conjunto Quimicas, Sao Paulo
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DOI: 10.1590/s2175-97902018000217491
ISSN: 1984-8250
WoS: 000440488300001
Scopus: 2-s2.0-85050893254
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Tehnološko-metalurški fakultetTY - JOUR AU - Tolić, Ljiljana AU - Grujić, Svetlana AU - Laušević, Mila PY - 2018 UR - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3881 AB - 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, thennal 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. PB - University of Sao Paulo, Conjunto Quimicas, Sao Paulo T2 - Brazilian Journal of Pharmaceutical Sciences T1 - Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products IS - 2 VL - 54 DO - 10.1590/s2175-97902018000217491 ER -
@article{ author = "Tolić, Ljiljana and Grujić, Svetlana and Laušević, Mila", year = "2018", 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, thennal 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.", publisher = "University of Sao Paulo, Conjunto Quimicas, Sao Paulo", journal = "Brazilian Journal of Pharmaceutical Sciences", 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", number = "2", volume = "54", doi = "10.1590/s2175-97902018000217491" }
Tolić, L., Grujić, S.,& Laušević, M.. (2018). Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products. in Brazilian Journal of Pharmaceutical Sciences University of Sao Paulo, Conjunto Quimicas, Sao Paulo., 54(2). https://doi.org/10.1590/s2175-97902018000217491
Tolić L, Grujić S, Laušević M. Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products. in Brazilian Journal of Pharmaceutical Sciences. 2018;54(2). doi:10.1590/s2175-97902018000217491 .
Tolić, Ljiljana, Grujić, Svetlana, Laušević, Mila, "Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products" in Brazilian Journal of Pharmaceutical Sciences, 54, no. 2 (2018), https://doi.org/10.1590/s2175-97902018000217491 . .