TY  - JOUR
AU  - Protić, Ana
AU  - Živanović, Ljiljana
AU  - Radisić, Marina
AU  - Lusevic, Mila
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1559
AB  - Multicriteria decision making methodology in combination with experimental design has been applied for optimization of stability-indicating LC/DAD method of Mycophenolate mofetil and its degradation products. Via fractional factorial design variables with statistically significant impact on retention parameters of the investigated substances were defined and then thoroughly optimized toward four chromatographic responses combining central composition design and desirability function. The separation was achieved on Chromolith column (C18e, 100x4.6mm) with the mobile phase consisted of acetonitrile0.015M KH2PO4 (pH 4.4) (28:72, v/v). The flow rate of the mobile phase was 2mL/min and the detection was performed using PDA detector at 215nm. The method has been suitably modified for LC/MS/MS analysis. The ammonium-acetate buffer was used instead of phosphate buffer and pH of the water phase was adjusted with acetic acid. The flow rate was 1mLmin-1. The substance was subjected to stress conditions (0.01M NaOH, 1M HCl, 3-30% H2O2, 70 degrees C and day light). It resulted in formation of Mycophenolic acid and two oxidation products. The substance showed to be stable only towards photolysis. The LC/MS/MS values and fragmentation pattern of two unknown oxidation products were used in its characterization.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Journal of Liquid Chromatography & Related Technologies
T1  - Impurity profiling of mycophenolate mofetil with the assisstance of desirability function in method development
VL  - 34
IS  - 12
SP  - 1014
EP  - 1035
DO  - 10.1080/10826076.2011.569809
ER  - 

@article{
author = "Protić, Ana and Živanović, Ljiljana and Radisić, Marina and Lusevic, Mila",
year = "2011",
abstract = "Multicriteria decision making methodology in combination with experimental design has been applied for optimization of stability-indicating LC/DAD method of Mycophenolate mofetil and its degradation products. Via fractional factorial design variables with statistically significant impact on retention parameters of the investigated substances were defined and then thoroughly optimized toward four chromatographic responses combining central composition design and desirability function. The separation was achieved on Chromolith column (C18e, 100x4.6mm) with the mobile phase consisted of acetonitrile0.015M KH2PO4 (pH 4.4) (28:72, v/v). The flow rate of the mobile phase was 2mL/min and the detection was performed using PDA detector at 215nm. The method has been suitably modified for LC/MS/MS analysis. The ammonium-acetate buffer was used instead of phosphate buffer and pH of the water phase was adjusted with acetic acid. The flow rate was 1mLmin-1. The substance was subjected to stress conditions (0.01M NaOH, 1M HCl, 3-30% H2O2, 70 degrees C and day light). It resulted in formation of Mycophenolic acid and two oxidation products. The substance showed to be stable only towards photolysis. The LC/MS/MS values and fragmentation pattern of two unknown oxidation products were used in its characterization.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "Impurity profiling of mycophenolate mofetil with the assisstance of desirability function in method development",
volume = "34",
number = "12",
pages = "1014-1035",
doi = "10.1080/10826076.2011.569809"
}

Protić, A., Živanović, L., Radisić, M.,& Lusevic, M.. (2011). Impurity profiling of mycophenolate mofetil with the assisstance of desirability function in method development. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 34(12), 1014-1035.
https://doi.org/10.1080/10826076.2011.569809

Protić A, Živanović L, Radisić M, Lusevic M. Impurity profiling of mycophenolate mofetil with the assisstance of desirability function in method development. in Journal of Liquid Chromatography & Related Technologies. 2011;34(12):1014-1035.
doi:10.1080/10826076.2011.569809 .

Protić, Ana, Živanović, Ljiljana, Radisić, Marina, Lusevic, Mila, "Impurity profiling of mycophenolate mofetil with the assisstance of desirability function in method development" in Journal of Liquid Chromatography & Related Technologies, 34, no. 12 (2011):1014-1035,
https://doi.org/10.1080/10826076.2011.569809 . .