Determination of 16 antineoplastic drugs by capillary electrophoresis with UV detection: Applications in quality control

Abstract

Two capillary electrophoresis (CE) methods were developed for the analysis of 16 antineoplastic drugs contained in injectable pharmaceutical formulations. A capillary zone electrophoresis (CZE) method coupled to UV was developed with a background electrolyte (BGE) made of a 100 mM phosphate buffer at pH 2.5 containing 50% v/v of acetonitrile and dynamic coating of capillaries with Ceofix®. This method allowed the analysis of doxorubicin, epirubicin, idarubicin, daunorubicin, irinotecan, topotecan, vincristine, vindesine, vinblastine, and vinorelbine in less than 8 min. A micellar electrokinetic chromatography (MEKC) method coupled to UV was also developed for the determination of methotrexate, pemetrexed, etoposide, etoposide phosphate, fludarabine phosphate, and 5-fluorouracil. A run time of 16 min was obtained with a BGE made of 50 mM borate buffer at pH 9.2 with 80 mM of sodium dodecyl sulfate (SDS) and 20% v/v of acetonitrile. For both methods, the applied voltage was 30 kV and the sample injection was performed in the hydrodynamic mode. All analyses were carried out in fused silica capillaries with an internal diameter of 50 μm and a total length of 64.5 cm. Both methods were validated and trueness values between 99.4 and 101.3% were obtained with repeatability and intermediate precision values of 0.5-1.8% for all drugs. These methods were found appropriate for controlling injectable pharmaceutical formulations containing antineoplastic drugs and successfully applied in quality control.

Analytical methodologies for determination of methotrexate and its metabolites in pharmaceutical, biological and environmental samples

“…CE using low amount of sample, cheap capillaries, high speed, and high resolution and efficiency has been proposed as another technique to separate MTX in different matrices, by Castro-Puyana et al., Cheng et al., and Guichard et al. [[115], [116], [117], [118]]. Due to the importance of cerebrospinal fluid (CSF) during chemotherapy and relapse, the evaluation of MTX and its metabolites in CSF was performed by triple-stacking CE [116].…”

Portable solid-state sensor for therapeutic monitoring of an antineoplastic drug; vinblastine in human plasma

“…The rapid body clearance, large distribution volume, and low plasma concentration of vinblastine necessitate a rapid, sensitive, and selective analytical method to achieve reliable pharmacokinetic studies. 13,14 Different methods have been reported in the literature for the determination of vinblastine including spectrophotometry, 15,16 thin layer chromatography, 17 high-performance liquid chromatography, [18][19][20][21][22][23][24][25][26] capillary electrophoresis, [27][28][29][30][31] and voltammetric methods. [32][33][34][35][36][37] As far as the authors' knowledge, no potentiometric sensor is reported in the literature for the determination of vinblastine.…”

Electrochemical Monitoring of Methotrexate Anticancer Drug in Human Blood Serum by Using in situ Solvothermal Synthesized Fe3O4/ITO Electrode

“…Therefore, developing a simple, rapid and highly sensitive method for MTX detection has received increasing attention. Recently, high‐performance liquid chromatography (HPLC) , capillary electrophoresis (CE) and fluorescence spectroscopy techniques were widely used as high accuracy techniques for monitoring of MTX in real samples. But, HPLC and CE are expensive instruments; also using fluorescence spectroscopy process needs complicated sample preparation processes, which limited their clinical applications.…”