<?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>1665-3521</journal-id>
<journal-title><![CDATA[Superficies y vacío]]></journal-title>
<abbrev-journal-title><![CDATA[Superf. vacío]]></abbrev-journal-title>
<issn>1665-3521</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Mexicana de Ciencia y Tecnología de Superficies y Materiales A.C.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1665-35212009000300007</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Desarrollo de un método y su validación para la determinación de melatonina en tabletas]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramírez Gutiérrez]]></surname>
<given-names><![CDATA[María del Socorro]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castineira]]></surname>
<given-names><![CDATA[Mirta]]></given-names>
</name>
<xref ref-type="aff" rid="A02"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Nieto]]></surname>
<given-names><![CDATA[Olga María]]></given-names>
</name>
<xref ref-type="aff" rid="A02"/>
</contrib>
</contrib-group>
<aff id="A01">
<institution><![CDATA[,Benemérita Universidad Autónoma de Puebla Facultad de Ciencias Químicas ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<aff id="A02">
<institution><![CDATA[,Universidad de la Habana Instituto de Farmacia y Alimentos ]]></institution>
<addr-line><![CDATA[Ciudad de la Habana ]]></addr-line>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2009</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2009</year>
</pub-date>
<volume>22</volume>
<numero>3</numero>
<fpage>29</fpage>
<lpage>32</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S1665-35212009000300007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S1665-35212009000300007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S1665-35212009000300007&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Se desarrolló y validó un método para la cuantificación de melatonina en materia prima y en forma farmacéutica tabletas por espectrofotometría ultravioleta. Se utilizaron soluciones patrones de melatonina y se evaluaron los siguientes parámetros: linealidad, precisión, robustez, exactitud y especificidad del método. Se obtuvieron resultados que mostraron que este método presenta linealidad entre 27 y 33 µg/mL, presento buena precisión, robustez en cuanto a las variaciones en la temperatura así como del pH y exactitud. La especificidad del método en tabletas no se vio comprometida con la presencia de excipientes.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[An analytical method was developed and validated for the quantification of melatonina in tablets by spectrophotometry, with ultraviolet. The parameters of specificity, linearity, exactness and precision were evaluated. The calibration curve was performed in the range from 27 to 33 µg/mL which was lineal. The results attained by parameters analyzed in the validation of the method were within the established limits. Neither excipients present in the formulation, interfere with the assay. The applied analytical method proved to be lineal, precise, specific and exact in the range of the studied concentrations.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Melatonina]]></kwd>
<kwd lng="es"><![CDATA[Espectrofotometría ultravioleta]]></kwd>
<kwd lng="en"><![CDATA[Melatonin]]></kwd>
<kwd lng="en"><![CDATA[Ultraviolet spectrophotometry]]></kwd>
</kwd-group>
</article-meta>
</front><body><![CDATA[  	    <p align="center"><font face="verdana" size="4"><b>Desarrollo de un m&eacute;todo y su validaci&oacute;n para la determinaci&oacute;n de melatonina en tabletas</b></font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="center"><font face="verdana" size="2"><b>Mar&iacute;a del Socorro Ram&iacute;rez Guti&eacute;rrez*<sup>1</sup>, Mirta Castineira<sup>2</sup>, Olga Mar&iacute;a Nieto<sup>3</sup></b></font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="justify"><font face="verdana" size="2"><sup><i>1</i></sup> <i>Facultad de Ciencias Qu&iacute;micas de la BUAP.</i> *<a href="mailto:marisoco07@yahoo.com.mx">marisoco07@yahoo.com.mx</a></font></p>  	    <p align="justify"><font face="verdana" size="2"><i><sup>2</sup> IFAL. Universidad de la Habana San L&aacute;zaro y L Vedado, Ciudad de la Habana.</i></font></p>  	    <p align="justify"><font face="verdana" size="2"><i><sup>3</sup> IFAL. Universidad de la Habana San L&aacute;zaro y L Vedado, Ciudad de la Habana.</i></font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="justify"><font face="verdana" size="2">Recibido: 30 de abril de 2009.    ]]></body>
<body><![CDATA[<br> 	Aceptado: 17 de julio de 2009.</font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="justify"><font face="verdana" size="2"><b>Resumen</b></font></p>  	    <p align="justify"><font face="verdana" size="2">Se desarroll&oacute; y valid&oacute; un m&eacute;todo para la cuantificaci&oacute;n de melatonina en materia prima y en forma farmac&eacute;utica tabletas por espectrofotometr&iacute;a ultravioleta. Se utilizaron soluciones patrones de melatonina y se evaluaron los siguientes par&aacute;metros: linealidad, precisi&oacute;n, robustez, exactitud y especificidad del m&eacute;todo. Se obtuvieron resultados que mostraron que este m&eacute;todo presenta linealidad entre 27 y 33 &micro;g/mL, presento buena precisi&oacute;n, robustez en cuanto a las variaciones en la temperatura as&iacute; como del pH y exactitud. La especificidad del m&eacute;todo en tabletas no se vio comprometida con la presencia de excipientes</font>.</p>  	    <p align="justify"><font face="verdana" size="2"><b>Palabras clave:</b> Melatonin; Espectrofotometr&iacute;a ultravioleta.</font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="justify"><font face="verdana" size="2"><b>Abstract</b></font></p>  	    <p align="justify"><font face="verdana" size="2">An analytical method was developed and validated for the quantification of melatonina in tablets by spectrophotometry, with ultraviolet. The parameters of specificity, linearity, exactness and precision were evaluated. The calibration curve was performed in the range from 27 to 33 &micro;g/mL which was lineal. The results attained by parameters analyzed in the validation of the method were within the established limits. Neither excipients present in the formulation, interfere with the assay. The applied analytical method proved to be lineal, precise, specific and exact in the range of the studied concentrations.</font></p>  	    <p align="justify"><font face="verdana" size="2"><b>Keywords:</b> Melatonina; Ultraviolet spectrophotometry.</font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    ]]></body>
<body><![CDATA[<p align="justify"><font face="verdana" size="2"><a href="/pdf/sv/v22n3/v22n3a7.pdf" target="_blank">DESCARGAR ART&Iacute;CULO EN FORMATO PDF</a></font></p>  	    <p align="justify"><font face="verdana" size="2">&nbsp;</font></p>  	    <p align="justify"><font face="verdana" size="2"><b>Referencias</b></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;1&#93;. Melatonin (Drug Evaluation). In: Gelman CR et al, editors. Drugdex&reg; Information System. <b>93</b>. Englewood: Micromedex Inc, 1997.    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689143&pid=S1665-3521200900030000700001&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;2&#93;. A, Brzezinski. Melatonin in humans. N Engl J Med; <b>336</b>, 186 (1997).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689145&pid=S1665-3521200900030000700002&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;3&#93;. A, Li Wan Po A. OTC Medications. Symptoms and Treatments of Common Illnesses, 2nd ed. Oxford: Blackwell Science, 203. (1997).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689147&pid=S1665-3521200900030000700003&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;4&#93;. Melatonin &#150; Prevention of jet lag (Drug Consults). In: Gelman CR et al, editors. Drugdex&reg;. Information System. Vol. 93. Englewood: Micromedex Inc, 1997.    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689149&pid=S1665-3521200900030000700004&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;5&#93;. J, Arendt et al. Alleviation of jet lag by melatonin: preliminary results of controlled double blind trial. Br Med J (Clin Res); <b>292</b>, 1170 (1986).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689151&pid=S1665-3521200900030000700005&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;6&#93;. K. Petrie et al. Effect of melatonin on jet lag after long haul flights. BMJ; <b>298</b>, 705 (1989).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689153&pid=S1665-3521200900030000700006&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;7&#93;. BJ, Holliman et al. Problems in assessment of acute melatonin overdose. South Med J; <b>90</b>, 451 (1997).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689155&pid=S1665-3521200900030000700007&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;8&#93;. D, Garfinkel et al. Improvement of sleep quality in elderly people by controlled&#45;release melatonin.. Lancet; <b>346</b>, 541(1995).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689157&pid=S1665-3521200900030000700008&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;9&#93;. IV, Zhdanova et al. Sleep&#45;inducing effects of low doses of melatonin ingested in the evening. Clin Pharmacol Ther; <b>57</b>, 552 (1995).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689159&pid=S1665-3521200900030000700009&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;10&#93;. PL, Canales et al. A Pharmacist's guide to transient insomnia. J Am Pharm Assoc; <b>36</b>, 421(1996).    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689161&pid=S1665-3521200900030000700010&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;11&#93;. ICH . Note for Guidance on Validation of Analytical Methods: Methodology. International Conference on Harmonization, 29 November 1995.    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689163&pid=S1665-3521200900030000700011&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>  	    <!-- ref --><p align="justify"><font face="verdana" size="2">&#91;12&#93;.The United States Pharmacopeia. USP XXVI. Rockville: United States Pharmacopeial Convention; 2003.    &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=9689165&pid=S1665-3521200900030000700012&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --></font></p>      ]]></body><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="book">
<article-title xml:lang="en"><![CDATA[Melatonin (Drug Evaluation)]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gelman]]></surname>
<given-names><![CDATA[CR]]></given-names>
</name>
</person-group>
<source><![CDATA[Drugdex® Information System]]></source>
<year>1997</year>
<volume>93</volume>
<publisher-loc><![CDATA[Englewood ]]></publisher-loc>
<publisher-name><![CDATA[Micromedex Inc]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Brzezinski]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Melatonin in humans]]></article-title>
<source><![CDATA[N Engl J Med]]></source>
<year>1997</year>
<volume>336</volume>
<page-range>186</page-range></nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Li Wan Po]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<source><![CDATA[OTC Medications. Symptoms and Treatments of Common Illnesses]]></source>
<year>1997</year>
<edition>2</edition>
<page-range>203</page-range><publisher-loc><![CDATA[Oxford ]]></publisher-loc>
<publisher-name><![CDATA[Blackwell Science]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="book">
<article-title xml:lang="en"><![CDATA[Melatonin - Prevention of jet lag (Drug Consults).]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gelman]]></surname>
<given-names><![CDATA[CR]]></given-names>
</name>
</person-group>
<source><![CDATA[Drugdex®. Information System]]></source>
<year>1997</year>
<volume>93</volume>
<publisher-loc><![CDATA[Englewood ]]></publisher-loc>
<publisher-name><![CDATA[Micromedex Inc]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Arendt]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Alleviation of jet lag by melatonin: preliminary results of controlled double blind trial]]></article-title>
<source><![CDATA[Br Med J (Clin Res)]]></source>
<year>1986</year>
<volume>292</volume>
<page-range>1170</page-range></nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Petrie]]></surname>
<given-names><![CDATA[K.]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Effect of melatonin on jet lag after long haul flights]]></article-title>
<source><![CDATA[BMJ]]></source>
<year>1989</year>
<volume>298</volume>
<page-range>705</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Holliman]]></surname>
<given-names><![CDATA[BJ]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Problems in assessment of acute melatonin overdose]]></article-title>
<source><![CDATA[South Med J]]></source>
<year>1997</year>
<volume>90</volume>
<page-range>451</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Garfinkel]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Improvement of sleep quality in elderly people by controlled-release melatonin]]></article-title>
<source><![CDATA[Lancet]]></source>
<year>1995</year>
<volume>346</volume>
<page-range>541</page-range></nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Zhdanova]]></surname>
<given-names><![CDATA[IV]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Sleep-inducing effects of low doses of melatonin ingested in the evening]]></article-title>
<source><![CDATA[Clin Pharmacol Ther]]></source>
<year>1995</year>
<volume>57</volume>
<page-range>552</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Canales]]></surname>
<given-names><![CDATA[PL]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[A Pharmacist's guide to transient insomnia]]></article-title>
<source><![CDATA[J Am Pharm Assoc]]></source>
<year>1996</year>
<volume>36</volume>
<page-range>421</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="">
<collab>ICH</collab>
<source><![CDATA[Note for Guidance on Validation of Analytical Methods: Methodology]]></source>
<year>29 N</year>
<month>ov</month>
<day>em</day>
</nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<collab>The United States Pharmacopeia</collab>
<source><![CDATA[USP XXVI]]></source>
<year>2003</year>
<publisher-loc><![CDATA[Rockville ]]></publisher-loc>
<publisher-name><![CDATA[United States Pharmacopeial Convention]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
