<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2221-2442</journal-id>
<journal-title><![CDATA[Revista CENIC Ciencias Químicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. CENIC Cienc. Quím.]]></abbrev-journal-title>
<issn>2221-2442</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Investigaciones Científicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2221-24422021000200161</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Validación de un método cromatográfico para la valoración del Metamizol sódico en la Dipirona-600 y el Espasmoforte]]></article-title>
<article-title xml:lang="en"><![CDATA[Validation of a chromatographic method for the assessment of sodium metamizole in Dipyrone-600 and Spasmoforte]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Contreras-Roura]]></surname>
<given-names><![CDATA[Jiovanna]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Guach-Wilson]]></surname>
<given-names><![CDATA[Susel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez-Martiatu]]></surname>
<given-names><![CDATA[Suharmy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lafferte-García]]></surname>
<given-names><![CDATA[Tania]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-Fernández]]></surname>
<given-names><![CDATA[Yesenia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Empresa Laboratorios AICA Laboratorio de Control de la Calidad Físico-Químico ]]></institution>
<addr-line><![CDATA[La Lisa La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<volume>52</volume>
<numero>2</numero>
<fpage>161</fpage>
<lpage>181</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2221-24422021000200161&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2221-24422021000200161&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2221-24422021000200161&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Dipirona-600 (inyectable), es una formulación farmacéutica con acción analgésica y antiinflamatoria no esteroideo (AINE) de un compuesto químico derivado de la pirazolona, Metamizol sódico, inhibidor de la síntesis de prostaglandinas. Debido al surgimiento y propagación de la enfermedad COVID-19 en Cuba y al cese de la importación de este medicamento desde China fue necesario realizar su producción en Cuba (UEB AICA+), para el tratamiento paliativo de la fiebre y el dolor en los pacientes con COVID-19 y otras afecciones. La valoración del Metamizol sódico (como ingrediente farmacéutico activo) en la Dipirona-600 y el Espasmoforte se realiza por Iodometría, método volumétrico que requiere condiciones controladas, porque diferentes factores pueden afectar su exactitud; además, la Dipirona es fotosensible y se oxida fácilmente. Debido a esto, el Laboratorio de Control de la Calidad físico-químico necesita disponer de un método sencillo, rápido y específico para garantizar la calidad del inyectable y para la realización de los estudios de estabilidad. Se validó un método isocrático en fase reversa por cromatografía líquida de alta resolución (HPLC) con detección UV para la valoración del Metamizol Sódico en la Dipirona-600 con vista a su introducción en el Laboratorio mencionado. Los parámetros de validación evaluados fueron: Especificidad, Linealidad, Exactitud y la Precisión (Repetibilidad y Precisión intermedia). Para la valoración del Metamizol sódico en el Esparmoforte (inyectable) sólo se evalúo la especificidad y la linealidad. El método cromatográfico para la valoración del Metamizol sódico, cumplió con los criterios de aceptación para cada parámetro de validación o desempeño evaluados y se empleó en el análisis de varios lotes de Dipirona-600 y un lote de Espasmoforte.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract Dipyrone-600 (injectable), is a pharmaceutical formulation with analgesic and non-steroidal anti-inflammatory action (NSAID) of a chemical compound derived from pyrazolone, Metamizole sodium, an inhibitor of prostaglandin synthesis. Due to the emergence and spread of the COVID-19 disease in Cuba and the cessation of the importation of this drug from China, it was necessary to carry out its production in Cuba (UEB AICA+), for the palliative treatment of fever and pain in patients with COVID-19 and other conditions. The valuation of Sodium Metamizole (as an active pharmaceutical ingredient) in Dipirona-600 and Espasmoforte is carried out by iodometry, a volumetric method that requires controlled conditions, because different factors can affect its accuracy; Furthermore, Dipyrone is photosensitive and oxidizes easily. Due to this, the Physico-chemical Quality Control Laboratory needs to have a simple, fast and specific method to guarantee the quality of the injectable and to carry out stability studies. An isocratic method in reversed phase was validated by high performance liquid chromatography (HPLC) with UV detection for the valuation of Metamizole Sodium in Dipyrone-600 with a view to its introduction in the mentioned Laboratory. The validation parameters evaluated were: Specificity, Linearity, Accuracy and Precision (Repeatability and Intermediate Precision). For the assessment of Metamizole sodium in Esparmoforte (injection), only specificity and linearity were assessed. The chromatographic method for the valuation of sodium Metamizole met the acceptance criteria for each validation or performance parameter evaluated and was used in the analysis of several batches of Dipirona-600 and one batch of Espasmoforte.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Dipirona]]></kwd>
<kwd lng="es"><![CDATA[Metamizol sódico]]></kwd>
<kwd lng="es"><![CDATA[Espasmoforte]]></kwd>
<kwd lng="es"><![CDATA[Cromatografía Líquida de Alta Resolución]]></kwd>
<kwd lng="es"><![CDATA[validación y valoración]]></kwd>
<kwd lng="en"><![CDATA[Dipyrone]]></kwd>
<kwd lng="en"><![CDATA[Sodium Metamizole]]></kwd>
<kwd lng="en"><![CDATA[Espasmoforte]]></kwd>
<kwd lng="en"><![CDATA[HPLC]]></kwd>
<kwd lng="en"><![CDATA[validation and titration]]></kwd>
</kwd-group>
</article-meta>
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