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

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Journal of Pharmaceutical Analysis 2016年第2期6卷 103-111页

作者： milagros montemurro maría m.de zan juan c.robles laboratorio de control de calidad de medicamentos Facultad de Bioqufmica y Ciendas Biologicas Universidad Nacional del Litoral Santa Fe Argentina

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.

关键词： HPLC Core-shell particles Methotrexate Drug monitoring

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Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals

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Journal of Pharmaceutical Analysis 2015年第5期5卷 296-306页

作者： Carla M.Teglia Milagros Montemurro María M.de Zan María S.Cmara laboratorio de control de calidad de medicamentos Facultad de Bioquimica y Ciencias BiologicasUniversidad Nacional del Litoral

An efficient generic static headspace gas chromatography （HSGC） method was developed, optimized and validated for the routine determination of several residual solvents （RS） in drug substance, using a strategy with two sets of calibration. Dimethylsulfoxide （DMSO） was selected as the sample diluent and internal standards were used to minimize signal variations due to the preparative step. A gas chroma- tograph from Agilent Model 6890 equipped with flame ionization detector （FID） and a DB-624 （30 m × 0.53 mm i.d., 3.00 μm film thickness） column was used. The inlet split ratio was 5：1. The influ- encing factors in the chromatographic separation of the analytes were determined through a fractional factorial experimental design. Significant variables： the initial temperature （IT）, the final temperature （FT） of the oven and the carrier gas flow rate （F） were optimized using a central composite design. Response transformation and desirability function were applied to find out the optimal combination of the chromatographic variables to achieve an adequate resolution of the analytes and short analysis time. These conditions were 30 ℃ for IT, 158 ℃ for FT and 1.90 mL/min for F. The method was proven to be accurate, linear in a wide range and very sensitive for the analyzed solvents through a comprehensive validation according to the ICH guidelines.

关键词： Headspace gas chromatographyResidual solventsPharmaceuticalsSurface response methodologydesirabiliW function

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New Amphiphilic Amino Acid derivatives for Efficient DNA Transfection in Vitro

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Advances in Chemical Engineering and Science 2017年第2期7卷 191-205页

作者： Lucía C.Pena María F.Argaraná María M.de Zan Antonella Giorello Sebastián Antuna Claudio C.Prieto Carolina M.I.Veaute Diana M.Müller LAQUIMAP Dto.Química OrgánicaUniversidad Nacional del LitoralSanta FeArgentina Cát.Microbiología General Universidad Nacional del LitoralSanta FeArgentina Laoratorio de control de medicamentos Universidad Nacional del LitoralSanta FeArgentina Instituto de Investigaciones en Catálisis y Petroquímica Universidad Nacional del LitoralSanta FeArgentina laboratorio de Cultivos Celulares Universidad Nacional del LitoralSanta FeArgentina laboratorio de Inmunología Básica Universidad Nacional del LitoralSanta FeArgentina

Nucleic acids-based therapies have recently developed as next-generation agents for treating and preventing viral infection, cancer, and genetic disorders, but their use is still limited due to its relatively poor delivery into targeted cells. We designed and synthesized new amphiphilic amino acid derivatives (cysteine-based) of low molecular weight, formed by the same pentapeptide (AG2: WWCOO) N-acylated, with different hydrophobic chains containing from 12 to 18 carbons, named AG2-Cn (N), which dimerize by oxidation in the presence of pLenti-CMV-GFP Puro plasmid (P) in the respective gemini. We determined transfection efficiency, critical micelle concentration, particle size, ζ-potential and cytotoxicity for the derivatives obtained. We found that all the synthesized compounds were active for DNA delivery and had greater ability to transfect CHO-K1 cells. In particular, AG2-C18 is a promising carrier for gene delivery because it showed no cytotoxicity and its activity was greater than or equal to the commercial actives currently used.

关键词： Amphiphile N-Acylated Cysteine Gemini Ornithine Transfection

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