<?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>0034-7418</journal-id>
<journal-title><![CDATA[Revista Colombiana de Ciencias Químico - Farmacéuticas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. colomb. cienc. quim. farm.]]></abbrev-journal-title>
<issn>0034-7418</issn>
<publisher>
<publisher-name><![CDATA[Departamento de Farmácia, Facultad de Ciencias, Universidade Nacional da Colombia]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0034-74182020000200509</article-id>
<article-id pub-id-type="doi">10.15446/rcciquifa.v49n2.89926</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Forced degradation studies and stability-indicating liquid chromatography method for determination of tirofiban hydrochloride and synthetic impurities]]></article-title>
<article-title xml:lang="pt"><![CDATA[Estudo da degradação forçada e método indicativo da estabilidade por cromatografía líquida para determinação de cloridrato de tirofibana e impurezas sintéticas]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Roll Feijó]]></surname>
<given-names><![CDATA[Adriane Lettnin]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hellwig]]></surname>
<given-names><![CDATA[Fernanda Macke]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Paim]]></surname>
<given-names><![CDATA[Clésio Soldateli]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Malesuik]]></surname>
<given-names><![CDATA[Marcelo Donadel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Federal University of Pampa  ]]></institution>
<addr-line><![CDATA[Uruguaiana RS]]></addr-line>
<country>Brazil</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Federal University of Pampa  ]]></institution>
<addr-line><![CDATA[Itaqui RS]]></addr-line>
<country>Brazil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2020</year>
</pub-date>
<volume>49</volume>
<numero>2</numero>
<fpage>509</fpage>
<lpage>522</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0034-74182020000200509&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0034-74182020000200509&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0034-74182020000200509&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY This study aimed to develop and validate a stability-indicating liquid chromatography method for the determination of tirofiban hydrochloride and two synthetic impurities (impurity A and impurity C). The method utilizes a RP-18 column (250 mm x 4.6 mm; 5 µm) with the PDA detector for quantitation. A mixture of triethylamine 0.1% (acidified to pH 5.5 with phosphoric acid) and acetonitrile was used as the mobile phase at a flow rate of 1 mL min-1 with gradient elution. The method presented satisfactory linearity, precision, accuracy and robustness, as well as low limits of detection and quantification, which demonstrate sensitivity in the determination of tirofiban and impurities A and C. It was selective for the determination of the drug and impurities analysed, without interference of the degradation products generated under forced conditions, demonstrating the stability-indicating capacity of the proposed method. Tirofiban showed to be practically stable to oxidative (30% H2O2 for 24 h) and thermal (75 °C for 24 h) conditions, but presented degradation to UVA light and acid hydrolysis, obeying the first order kinetics for both. In this way, it can be used as a stability-indicating method in the quality control of the raw material of tirofiban hydrochloride, as well as of the finished product. The obtained results demonstrate the importance of deepening the studies in this area, to guarantee the quality of commercialized pharmaceutical products.]]></p></abstract>
<abstract abstract-type="short" xml:lang="pt"><p><![CDATA[RESUMO Este estudo teve como objetivo desenvolver e validar método indicativo da estabilidade por cromatografía líquida para determinação de cloridrato de tirofibana e duas impurezas de síntese (impureza A e impureza C). O método utilizou coluna de fase reversa RP-18 (250 mm x 4,6 mm; 5 µm) e detector PDA para quantificação. A fase móvel foi composta por uma mistura de trietilamina 0,1% (acidificada com ácido fosfórico para pH 5,5) e acetonitrila, à vazão de 1 mL/min, no modo gradiente. O método apresentou linearidade, precisão, exatidão, robustez, bem como baixos limites de detecção e quantificação, demonstrando sensibilidade na determinação da tirofibana e impurezas A e C. O método apresentou seletividade na determinação do fármaco e das impurezas, sem interferência dos produtos de degradação gerados na degradação forçada da tirofibana, demonstrando sua capacidade indicativa de estabilidade. O fármaco apresentou-se estável a oxidação (H2O2 30% por 24 h) e a degradação térmica (75 °C por 24 h), mas degradou frente à luz UVA e hidrolise ácida, obedecendo cinética de primeira ordem para ambas. Dessa forma, pode ser utilizado como um método indicativo de estabilidade no controle de qualidade da matéria -prima do cloridrato de tirofibana, bem como no produto acabado. Os resultados obtidos demonstram a importância de aprofundar os estudos na área, com intuito de garantir a qualidade dos produtos farmacêuticos comercializados.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Degradation products]]></kwd>
<kwd lng="en"><![CDATA[HPLC]]></kwd>
<kwd lng="en"><![CDATA[impurities]]></kwd>
<kwd lng="en"><![CDATA[tirofiban]]></kwd>
<kwd lng="en"><![CDATA[stability]]></kwd>
<kwd lng="pt"><![CDATA[Produtos de degradação]]></kwd>
<kwd lng="pt"><![CDATA[HPLC]]></kwd>
<kwd lng="pt"><![CDATA[impurezas]]></kwd>
<kwd lng="pt"><![CDATA[tirofibana]]></kwd>
<kwd lng="pt"><![CDATA[estabilidade]]></kwd>
</kwd-group>
</article-meta>
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