diario americano de Administración de Medicamentos y Terapéutica Acceso abierto

Abstracto

Congreso HPLC 2018: Solución de cromatografía iónica para mercados farmacéuticos aplicados - Sergio Guazzotti - Thermo Fisher Scientific

Sergio Guazzotti

Abstracto:

Una comprensión precisa de la sustancia de cualquier componente farmacéutico ayuda a garantizar tanto la suficiencia del medicamento como la seguridad del paciente. En los últimos años, ha habido una gran mejora en las estrategias y procedimientos expositivos que garantizan la investigación básica de las características de calidad de los productos farmacéuticos. Las soluciones que ofrecen los sistemas de cromatografía iónica Dionex son ampliamente aceptadas y están ganando terreno debido a los pocos avances mecánicos y ventajas en estos sistemas de CI Dionex.

The gadgets and techniques utilized for medicate ID and its consistence with administrative gauges should be solid and delicate. The most favored technique to break down various kinds of pharmaceutical arrangements, pharmaceuticals, or even body liquids for deciding the dynamic fixings, follow contaminations, excipients and metabolites happening as natural or inorganic particles or polar substances, is particle chromatography (IC). Utilizing particle chromatography, a few substances can be distinguished in a solitary examination quickly, and synthetically comparative analytes can likewise be separated. The scope of analyte focus that can be estimated by this technique shifts from ng/L to rates. Another bit of leeway of the IC strategy is the accessibility of a wide scope of elution frameworks and partition sections that empower investigation of for all intents and purposes a wide range of analytes. Additionally, choosing a proper discovery technique or test arrangement strategy takes out the meddling impacts of the example network. A large portion of the current IC frameworks highlight inline test groundwork for helpful activity. Other than improving the IC strategy, mechanization additionally eases the danger of tainting and wrong outcomes impressively by limiting human intercession. Particle chromatography (IC) is the strategy for decision to decide dynamic fixings, excipients, and hints of polluting influences, just as metabolites as natural and inorganic particles or polar substances, in various pharmaceuticals, pharmaceutical arrangements, and even body liquids. It can decide a few substances inside an exceptionally brief timeframe in a solitary investigation — and can even recognize synthetically comparable analytes. The grouping of analytes can change from ng/L up to the percent extend. The huge choice of division segments and elution frameworks accessible makes IC helpful for practically any sort of analyte. Meddling impacts brought about by the example lattice can undoubtedly be kept away from by utilizing the correct example planning or picking an appropriate recognition technique. In-line test arrangement is an element of numerous cutting edge IC frameworks, as the focal point of ongoing advances in IC has been primarily on usability. Be that as it may, comfort isn't the main favorable position brought via computerization of the IC procedure: Reducing human impedance to a base likewise implies decreasing the odds of mix-ups and defilement.

Particle Chromatography has become a fundamental apparatus of the pharmaceutical systematic scientist. The high affectability of the method, combined with the wide unique working reach made conceivable with current high-limit fixed stages makes it perfect for the examination of particles in pharmaceutical applications. The blend of inclinations and smothered conductivity location gives a ground-breaking screening device to the investigation of particles in tranquilize substances and in pharmaceutical plans, giving a premise to the examination of counterions, added substances and assembling results. Particle chromatography as we probably am aware it today started with the spearheading work of Small, Stevens and Bauman. It has been developed various fronts, presently covering an amazingly wide assortment of analytes, and has seen noteworthy upgrades in fixed stage plan, chromatographic execution, recognition affectability, silencer structure and electrolytic age of eluents. Particle trade chromatography was generally utilized in HPLC a long time before the approach of particle chromatography. Furthermore, even now there are the individuals who take the point of view that particle chromatography is basically an advertising ploy to cut out a specialty for a HPLC instrument with a particle investigation center. Notwithstanding, in all actuality while particle investigation can positively be practiced on a traditional HPLC, ideal execution and dependability direct unique structure contemplations which eventually bring about central instrumentation contrasts. For instance, it is notable that hardened steel isn't promptly consumed by soluble arrangements so it is enticing to recommend that anion examination utilizing carbonate-bicarbonate cushioned eluent frameworks ought to be promptly agreeable to use with standard tempered steel HPLC instrumentation. Be that as it may, truth be told, the defensive oxide film on the outside of passivated treated steel parts is assaulted by rehashed cycles among acidic and antacid arrangements, at last evacuating the passivation layer and rendering the hardened steel vulnerable to pitting consumption. Thus, devoted instrumentation reasonable for use with both acidic and fundamental eluent frameworks perform significantly more dependably when all wetted surfaces are made out of idle materials, for example, PEEK, KelF, and so on. Thus, particle chromatography has come to be a subdiscipline of HPLC with specific instrumentation, consumables and identifiers.

These progressions incorporate prevalent precision, high-throughput, improved dependability, and natural wellbeing concerns which altogether contribute towards the basic examination of the medication element of intrigue. IC fundamentally depends on stifled just as non-smothered conductivity recognitions for ionic species in pharmaceutical examples. Dionex IC frameworks can precisely break down different anions/cations in a solitary infusion, in this way, quickening the examination throughput. The profitability can be additionally improved by changing over the single channel framework to a double channel framework where two distinct examples can be simultaneously broke down. Latest progression, Consumables Device Monitor, can naturally distinguish and tracks the establishment time, use, and execution measurements of all the introduced IC consumables. This component can decrease any related vacation because of consumable establishment blunders and can even timetable preventive systems for upkeeps. Such savvy abilities can essentially improve the profitability just as diminish the weight on the investigators' time in a quick paced pharmaceutical research facility. All cutting edge IC frameworks can make eluents naturally, permitting the steady and solid creation of high immaculateness IC eluent focuses. The main routine reagent at that point required is high-immaculateness water. Subsequently, the instrument siphon seals and cylinders just come into contact with deionized water rather than acids and bases which can accelerate. This broadens the lifetime of siphon seals and cylinders, and altogether decreases the general siphon upkeep necessities.

Dionex ICS-6000 HPIC framework being able to create and run various strategies for a solitary example or for various examples is progressively significant for logical research facilities. A profoundly adaptable particle chromatography (IC) framework furnishes you with the opportunity to create, investigate, and run various strategies at the same time. Dionex IC frameworks are continually developing with the changing occasions and needs. Late IC frameworks are outfitted with a tablet supporting 11 distinct dialects with an instinctive interface. This tablet control empowers direct neighborhood control of the framework and its status. All these improved abilities and headways have just prompted the fruitful appropriation of IC for breaking down ionic species in pharmaceutical applications.

Biography:

Sergio Guazzotti es Director de Marketing Global Sénior para cromatografía iónica y preparación de muestras en Thermo Fisher Scientific. Antes de este puesto, fue Director de Marketing Global para cromatografía de gases/cromatografía de gases-espectrometría de masas también en Thermo Fisher Scientific. Se incorporó a la empresa en 2008 como Gerente Sénior de Marketing Estratégico Global para HPLC y, posteriormente, fue designado Gerente Sénior de Integración para ayudar en la integración de Dionex Corporation en Thermo Fisher Scientific. Antes de incorporarse a Thermo Fisher Scientific, fue Vicepresidente de Ingeniería y Servicios Técnicos en Nanostream, Inc. Anteriormente en su carrera, fue Profesor de Química Analítica en la Universidad de California, San Diego. Tiene un doctorado en Química de la Universidad de California.

Nota al pie: Este trabajo se presenta parcialmente en la 6ª ^Conferencia y Exhibición Internacional sobre Avances en Técnicas de Cromatografía y HPLC el 2 y 3 de agosto de 2018, celebrada en Barcelona, ​​España.