The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of imatinib mesylate and of the impurity product in Glivec(R) capsules (Novartis, Switzerland). Separations were performed on a X Terra(TM) 150 mm 4.6 mm, 5 mum particle size column at 25 degreesC. The mobile phase was a mixture of methanol-water-triethylamine (25:74: 1, v/v/v) with flow rate of 1.0 ml min(-1). pH value of water-triethylamine (TEA) was adjusted to 2.4 with orthophosphoric acid before adding of methanol. UV detection was performed at 267 nm. Acetaminophen was used as an internal standard. The method was validated statistically for its selectivity, linearity, precision, accuracy and robustness. Due to its speed and accuracy, the method may be used for quality control analyses.
Keywords:
imatinib mesylate
Source:
Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2004, 800, 1-2, 253-258
TY - JOUR
AU - Ivanović, D
AU - Medenica, Mirjana
AU - Jančić, Biljana
AU - Malenović, Anđelija
PY - 2004
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/544
AB - The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of imatinib mesylate and of the impurity product in Glivec(R) capsules (Novartis, Switzerland). Separations were performed on a X Terra(TM) 150 mm 4.6 mm, 5 mum particle size column at 25 degreesC. The mobile phase was a mixture of methanol-water-triethylamine (25:74: 1, v/v/v) with flow rate of 1.0 ml min(-1). pH value of water-triethylamine (TEA) was adjusted to 2.4 with orthophosphoric acid before adding of methanol. UV detection was performed at 267 nm. Acetaminophen was used as an internal standard. The method was validated statistically for its selectivity, linearity, precision, accuracy and robustness. Due to its speed and accuracy, the method may be used for quality control analyses.
PB - Elsevier Science BV, Amsterdam
T2 - Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences
T1 - Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec (R) capsules
VL - 800
IS - 1-2
SP - 253
EP - 258
DO - 10.1016/j.jchromb.2003.10.018
ER -
@article{
author = "Ivanović, D and Medenica, Mirjana and Jančić, Biljana and Malenović, Anđelija",
year = "2004",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/544",
abstract = "The reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of imatinib mesylate and of the impurity product in Glivec(R) capsules (Novartis, Switzerland). Separations were performed on a X Terra(TM) 150 mm 4.6 mm, 5 mum particle size column at 25 degreesC. The mobile phase was a mixture of methanol-water-triethylamine (25:74: 1, v/v/v) with flow rate of 1.0 ml min(-1). pH value of water-triethylamine (TEA) was adjusted to 2.4 with orthophosphoric acid before adding of methanol. UV detection was performed at 267 nm. Acetaminophen was used as an internal standard. The method was validated statistically for its selectivity, linearity, precision, accuracy and robustness. Due to its speed and accuracy, the method may be used for quality control analyses.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences",
title = "Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec (R) capsules",
volume = "800",
number = "1-2",
pages = "253-258",
doi = "10.1016/j.jchromb.2003.10.018"
}
Ivanović D, Medenica M, Jančić B, Malenović A. Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec (R) capsules. Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences. 2004;800(1-2):253-258
Ivanović, D., Medenica, M., Jančić, B.,& Malenović, A. (2004). Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec (R) capsules.
Journal of Chromatography B-Analytical Technologies in the Biomedical and Life SciencesElsevier Science BV, Amsterdam., 800(1-2), 253-258.
https://doi.org/10.1016/j.jchromb.2003.10.018
Ivanović D, Medenica Mirjana, Jančić Biljana, Malenović Anđelija, "Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec (R) capsules" 800, no. 1-2 (2004):253-258,
https://doi.org/10.1016/j.jchromb.2003.10.018 .
