Optimized high performance liquid chromatography-ultraviolet detection method using core-shell particles for the therapeutic monitoring of methotrexate

• Published in: Journal of pharmaceutical analysis Vol. 6; no. 2; pp. 103 - 111
• Main Authors: Montemurro, Milagros, De Zan, María M., Robles, Juan C.
• Format: Journal Article
• Language: English
• Published: China Elsevier B.V 01.04.2016; Laboratorio de Control de Calidad de Medicamentos, Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral, Santa Fe, Argentina; Xi'an Jiaotong University; Elsevier
• Subjects: Core–shell particles; Drug monitoring; HPLC; Methotrexate; Original; 抗肿瘤药物; 核壳粒子; 检测法; 治疗药物; 甲氨蝶呤; 监测; 紫外; 高效液相色谱法; Drug monitoring; Methotrexate; Core–shell particles; HPLC; Core-shel particles
• ISSN: 2095-1779; 2214-0883
• DOI: 10.1016/j.jpha.2015.12.001

Methotrexate （MTX） is an antineoplastic drug, and due to its high toxicity, the therapeutic drug mon- itoring is strictly conducted in the clinical practice. The chemometric optimization and validation of a high performance liquid chromatography （HPLC） method using core-shell particles is presented for the determination of MTX in plasma during therapeutic monitoring. Experimental design and response surface methodology （RSM） were applied for the optimization of the chromatographic system and the analyte extraction step. A Poroshel1120 EC-C18 （3.0 mm × 75 mm, 2.7 μm） column was used to obtain a fast and efficient separation in a complete run time of 4 min. The optimum conditions for the chroma- tographic system resulted in a mobile phase consisting of acetic acid/sodium acetate buffer solution （85.0 mM, pH =4.00） and 11.2% of acetonitrile at a flow rate of 0.4 mL/min. Selectivity, linearity, accuracy and precision were demonstrated in a range of 0.10-6.0 μM of MTX. The application of the optimized method required only 150μL of patient plasma and a low consumption of solvent to provide rapid re- sults.