Reversed-phase liquid chromatography analysis of imatinib mesylate and impurity product in Glivec capsules.
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 capsules (Novartis, Switzerland). Separations were performed on a X Terra 150 mm x 4.6 mm, 5 microm particle size column at 25 degrees C. 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.
Ivanovic
D
D
Department of Drug Analysis, Faculty of Pharmacy, Belgrade, Yugoslavia.
Medenica
M
M
Jancic
B
B
Malenovic
A
A
D000970:Antineoplastic Agents / Q000032:analysis*; D001549:Benzamides; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D006863:Hydrogen-Ion Concentration; D000068877:Imatinib Mesylate; D007202:Indicators and Reagents; D010879:Piperazines / Q000032:analysis*; D011743:Pyrimidines / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D013757:Tetraethylammonium Compounds / Q000737:chemistry
D000970:Antineoplastic Agents; D001549:Benzamides; D002214:Capsules; D007202:Indicators and Reagents; D010879:Piperazines; D011743:Pyrimidines; D012996:Solutions; D013757:Tetraethylammonium Compounds; D000068877:Imatinib Mesylate