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<front>
<journal-meta>
<journal-id journal-id-type="publisher">AFJPS</journal-id>
<journal-title>African Journal of Pharmaceutical Sciences</journal-title>
<issn pub-type="epub">2789-5092</issn>
<publisher>
<publisher-name>SvedbergOpen</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="other">afjps-1-1-004</article-id>
<doi-group>
<article-doi><ext-link ext-link-type="uri" xmlns:xlink="https://doi.org/" xlink:href="10.51483/AFJPS.1.1.2021.40-46">10.51483/AFJPS.1.1.2021.40-46</ext-link></article-doi>
</doi-group>
<article-categories>
<subj-group>
<subject>Research Paper</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Design and Validation of UV Spectrophotometric Method for Estimation and the Routine Quality Control Analysis of Sildenafil Citrate in Bulk and in Tablet Formulations</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name><surname>Ibrahim</surname><given-names>Mahmoud A.</given-names></name>
<xref ref-type="aff" rid="aff001"><sup>1</sup></xref>
</contrib>
<contrib contrib-type="author">
<name><surname>Magbool</surname><given-names>Fatehalrahman F</given-names></name>
<xref ref-type="aff" rid="aff002"><sup>2</sup></xref>
<xref ref-type="corresp" rid="cor001"><sup>*</sup></xref>
</contrib>
<contrib contrib-type="author">
<name><surname>Gamil</surname><given-names>Abdrhman Mahmoud</given-names></name>
<xref ref-type="aff" rid="aff003"><sup>3</sup></xref>
</contrib>
<contrib contrib-type="author">
<name><surname>Adam</surname><given-names>Mohamd E.</given-names></name>
<xref ref-type="aff" rid="aff004"><sup>4</sup></xref>
</contrib>
</contrib-group>
<aff id="aff001"><sup>1</sup><deptname>College of Pharmacy, Department of Pharmaceutical Analysis, Ribat National University</deptname>, <instcountry>Sudan</instcountry>. E-mail: <email>mahmoudbutre@gmail.com</email></aff>
<aff id="aff002"><sup>2</sup><deptname>Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University</deptname>, <instcountry>Sudan</instcountry>. E-mail: <email>fmagbool@yahoo.com</email></aff>
<aff id="aff003"><sup>3</sup><deptname>Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University</deptname>, <instcountry>Sudan</instcountry>. E-mail: <email>Abdrahmangamil@gmail.com</email></aff>
<aff id="aff004"><sup>4</sup><deptname>Department of Chemistry, Faculty of Pharmacy, University of Khartoum</deptname>, <instaddress>P.O. Box 1998, Khartoum</instaddress>, <instcountry>Sudan</instcountry>. E-mail: <email>dackouk2015@gmail.com</email></aff>
<author-notes>
<corresp id="cor001"><sup>*</sup>Corresponding author: Fatehalrahman F. Magbool, <deptname>Department of Pharmaceutics, Faculty of Pharmacy, Al-Neelain University</deptname>, <instcountry>Sudan</instcountry>. E-mail: <email>fmagbool@yahoo.com</email></corresp>
</author-notes>
<pub-date pub-type="ppub">
<month>09</month>
<year>2021</year>
</pub-date>
<volume>1</volume>
<issue>1</issue>
<fpage>40</fpage>
<lpage>46</lpage>
<abstract>
<title>Abstract</title>
<p>A Simple, sensitive, specific, UV Spectrophotometric method has been designed and developed for the determination of sildenafil citrate in bulk power and in pharmaceutical dosage form as well as its application for the routine quality control analysis of Sildenafil in bulk as well as in tablet formulations. The optimum condition for the analysis of the drug was established. Sildenafil citrate exhibiting absorption at 295 nm. The proposed method exhibited good levels of detection and quantitation. The specificity of the method was determined by checking the interference of placebo with analyte. There was no interference is observed. The regression equation for the Beer-Lambert&#x2019;s plot of pure Sildenafil citrate was found to be; <italic>Y</italic> &#x003D; 0.190 <italic>x</italic> and the correlation coefficient (<italic>R</italic><sup>2</sup>) of 0.9990. The Beer&#x2019;s plot was obeyed in concentration range between 0.001-0.005 mg/mL. There is good correlation between absorbance and concentration. Which is the basis of this method of analysis. The repeatability and intermediate precision were also assessed. The developed method was found to be precise as the &#x0025; RSD values. The application of the validated method to the three brands showed that all brands had values within the range specified in the IP (90110&#x0025;). The results and the statistical parameters demonstrate that the proposed UV spectrophotometric method is simple, rapid, specific, accurate and precise. Since the method can be used for estimation and routine quality control of Sildenafil in bulk as well as in tablet formulations.</p>
</abstract>
<kwd-group>
<title>Keywords</title>
<kwd>Sildenafil citrate</kwd>
<kwd>UV Spectrophotometric method</kwd>
<kwd>Validation</kwd>
<kwd>Correlation coefficient</kwd>
<kwd>Quality control</kwd>
</kwd-group>
<counts>
<ref-count count="25"/>
<page-count count="7"/>
</counts>
</article-meta>
</front>
<back>
<ref-list>
<title>References</title>
<ref id="bib001"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Abd-ELbary</surname><given-names>A.</given-names></name></person-group>, <etal>et al.</etal> (<year>2004</year>), <article-title>Stability Indicating High Performance Liquid Chromatographic Assay for the Determination of Sildenafil Citrate in Bulk and in Formulations</article-title>. <source>Chromatographia</source> <volume>59</volume>(<issue>9-10</issue>), <fpage>561</fpage>&#x2013;<lpage>566</lpage>.</citation></ref>
<ref id="bib002"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Al-Omari</surname><given-names>M.M.</given-names></name><name><surname>Zughul</surname><given-names>M.B.</given-names></name><name><surname>Davies</surname><given-names>J.E.D.</given-names></name><name><surname>Badwan</surname><given-names>A.A.</given-names></name></person-group> (<year>2006</year>). <article-title>Sildenafil/Cyclodextrin Complexation: Stability Constants, Thermodynamics, and Guest-host Interactions probed by 1H NMR and Molecular Modeling Studies</article-title>. <source>J Pharm Biomed Anal</source>., ;<volume>41</volume>, <fpage>857</fpage>&#x2013;<lpage>65</lpage>.</citation></ref>
<ref id="bib003"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Altiokka</surname><given-names>G.</given-names></name></person-group> <etal>et al.</etal> (<year>2001</year>), <article-title>FIA of Sildenafil Citrate using UV-detection</article-title>. <source>Journal of Pharmaceutical and Biomedical Analysis</source>, <volume>25</volume>(<issue>2</issue>), <fpage>339</fpage>&#x2013;<lpage>342</lpage>.</citation></ref>
<ref id="bib004"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Baokar</surname><given-names>Shrikrishna.</given-names></name><name><surname>Pawar</surname><given-names>Vinod.</given-names></name><name><surname>Sonawane</surname><given-names>S.H.</given-names></name></person-group> (<year>2011</year>). <article-title>High Performance Liquid Chromatographic Method Development and Validation of Cholesterol Inhibitor Drug</article-title>. <source>Journal of Pharmacy Research</source>, <volume>4</volume>(<issue>7</issue>), <fpage>2313</fpage>&#x2013;<lpage>2316</lpage>.</citation></ref>
<ref id="bib005"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Batista</surname><given-names>E.F.</given-names></name></person-group> <etal>et al.</etal> (<year>2010</year>). <article-title>Differential Pulse Voltammetric Determination of Sildenafil Citrate (Viagra) In Pharmaceutical Formulations Using a Boron-doped Diamond Electrode</article-title>. <source>Analytical Letters</source>, <volume>43</volume>(<issue>2010</issue>), <fpage>1046</fpage>&#x2013;<lpage>1054</lpage>.</citation></ref>
<ref id="bib006"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Berzas</surname><given-names>J.J.</given-names></name></person-group> <etal>et al.</etal> (<year>2002</year>). <article-title>Validation of a Capillary Gas Chromatographic Method for the Determination of Sildenafil Citrate in its Pharmaceutical Formulations (Viagra). Experimental Design for Evaluating the Ruggedness of the Method</article-title>. <source>Chromatographi,a</source>, <volume>55</volume>(<issue>9/10</issue>), <fpage>601</fpage>&#x2013;<lpage>606</lpage>.</citation></ref>
<ref id="bib007"><citation citation-type="book"><collab>British Pharmacopoeia</collab>. (<year>2015</year>). <source>British Pharmacopoeia Commission</source>, <publisher-loc>London</publisher-loc>. <volume>3</volume>, <fpage>320</fpage>.</citation></ref>
<ref id="bib008"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Card</surname><given-names>G.</given-names></name>L, <name><surname>England</surname><given-names>B.P.</given-names></name><name><surname>Suzuki</surname><given-names>Y.</given-names></name><name><surname>Fong</surname><given-names>D.</given-names></name><name><surname>Powell</surname><given-names>B.</given-names></name><name><surname>Lee</surname><given-names>B.</given-names></name></person-group> <etal>et al.</etal> (<year>2004</year>). <article-title>Structural Basis for the Activity of Drugs that Inhibit Phosphodiesterases</article-title>. <source>Structure</source>, <volume>12</volume>, <fpage>2233</fpage>&#x2013;<lpage>47</lpage>.</citation></ref>
<ref id="bib009"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Corbin</surname><given-names>J.D.</given-names></name><name><surname>Francis</surname><given-names>S.H.</given-names></name></person-group> (<year>1999</year>). <article-title>Cyclic GMP Phosphodiesterase-5: target of Sildenafil</article-title>. <source>J Biol Chem</source>., <volume>274</volume>, <fpage>13729</fpage>&#x2013;<lpage>32</lpage>.</citation></ref>
<ref id="bib010"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Do</surname><given-names>T.T.</given-names></name></person-group> <etal>et al.</etal> (<year>2015</year>). <article-title>Simultaneous Detection of Three Phosphodiesterase Type 5 Inhibitors and Eight of Their Analogs in Lifestyle Products and Screening for Adulterants by High-performance Thin-layer Chromatography</article-title>. <source>Journal of AOAC International</source>, <volume>98</volume>(<issue>5</issue>), <fpage>1226</fpage>&#x2013;<lpage>1233</lpage>.</citation></ref>
<ref id="bib011"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Farghali</surname><given-names>R.A.</given-names></name></person-group> <etal>et al.</etal> (<year>2015</year>). <article-title>Gold Nanoparticles-modified Screen-printed Carbon Electrode for Voltammetric Determination of Sildenafil Citrate (Viagra) in Pure Form, Biological and Pharmaceutical Formulations</article-title>. <source>International Journal of Electrochemical Science</source>, <volume>10</volume>(<issue>2</issue>), <fpage>1494</fpage>&#x2013;<lpage>1505</lpage>.</citation></ref>
<ref id="bib012"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Fidan</surname><given-names>A.K.</given-names></name></person-group> <etal>et al.</etal> (<year>2016</year>). <article-title>Simultaneous Determination of Sildenafil and Tadalafil in Legal Drugs, Illicit/Counterfeit Drugs, and Wastewater Samples by High-performance Liquid Chromatography</article-title>. <source>Journal of AOAC International</source>, <volume>99</volume>(<issue>4</issue>), <fpage>923</fpage>&#x2013;<lpage>928</lpage>.</citation></ref>
<ref id="bib013"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>G&#x00FC;zel</surname><given-names>R.</given-names></name></person-group> <etal>et al.</etal> (<year>2014</year>). <article-title>New Voltammetric Approach to the Quantitative Estimation of Sildenafil Citrate in Tablets Using Disposable Pencil Graphite Electrode</article-title>. <source>Sensor Letters</source>, <volume>12</volume>(<issue>11</issue>), <fpage>1675</fpage>&#x2013;<lpage>1681</lpage>.</citation></ref>
<ref id="bib014"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Kalyani</surname><given-names>K.</given-names></name></person-group> <etal>et al.</etal> (<year>2014</year>). <article-title>A Novel Stability indicating RP-HPLC Method for the Simultaneous Estimation of Sildenfii Citrate and Dapoxetine Hydrochloride in Bulk and Pharmaceutical Formulations</article-title>. <source>Der Pharmacia Letter</source>, <volume>7</volume>(<issue>10</issue>), <fpage>98</fpage>&#x2013;<lpage>106</lpage>.</citation></ref>
<ref id="bib015"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Kloner</surname><given-names>R.A.</given-names></name><name><surname>Jarow</surname><given-names>J.P.</given-names></name></person-group> (<year>1999</year>). <article-title>Erectile Disfunction and Sildenafil Citrate and Cardiologists</article-title>. <source>Am J Cardiol</source>., <volume>83</volume>(<issue>4</issue>), <fpage>576</fpage>&#x2013;<lpage>82</lpage>.</citation></ref>
<ref id="bib016"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Li</surname><given-names>J.</given-names></name></person-group> <etal>et al.</etal> (<year>2017</year>). <article-title>Solid-phase Extraction Assisted Dispersive Liquid Liquid Microextraction Based on Solidification of Floating Organic Droplet to Determine Sildenafil and Its Analogues in Dietary Supplements</article-title>. <source>Journal of Separation Science</source>, <volume>40</volume>(<issue>3</issue>), <fpage>3120</fpage>&#x2013;<lpage>3129</lpage>.</citation></ref>
<ref id="bib017"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Lopes</surname></name><name><surname>Junior</surname><given-names>A.C.V.</given-names></name></person-group> <etal>et al.</etal> (<year>2012</year>). <article-title>Determination of Sildenafil Citrate (Viagra&#x00AE;) in Various Pharmaceutical Formulations by Flow Injection Analysis with Multiple Pulse Amperometric Detection</article-title>. <source>Journal of Brazilian Chemical Society</source> <volume>23</volume>(<issue>1</issue>), <fpage>1800</fpage>&#x2013;<lpage>1806</lpage>.</citation></ref>
<ref id="bib018"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Mokhtar</surname><given-names>S.U.</given-names></name></person-group> <etal>et al.</etal> (<year>2016</year>). <article-title>Rapid Determination of Sildenafil and its Analogues in Dietary Supplements Using Gas Chromatography Triple Quadrupole Mass Spectrometry</article-title>. <source>Journal of Pharmaceutical and Biomedical Analysis</source>, <volume>121</volume>(<issue>2016</issue>), <fpage>188</fpage>&#x2013;<lpage>196</lpage>.</citation></ref>
<ref id="bib019"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Molleti</surname><given-names>S.</given-names></name></person-group> <etal>et al.</etal> (<year>2013</year>). <article-title>Determination of Sildenafil Citrate and its Related Substances in the Commercial Products and Tablet Dosage Form Using RP-UPLC</article-title>. <source>American Journal of PharmTech Research</source>, <volume>3</volume>(<issue>2</issue>), <fpage>378</fpage>&#x2013;<lpage>404</lpage>.</citation></ref>
<ref id="bib020"><citation citation-type="book"><collab>Pfizer Inc</collab>. (<year>1998</year>). <source>Viagra: compound data sheet</source>. <publisher-name>Pfizer Inc</publisher-name>.</citation></ref>
<ref id="bib021"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Rao</surname><given-names>N.</given-names></name><name><surname>Bagyalakshmi</surname><given-names>J.</given-names></name><name><surname>Ravi</surname><given-names>T.</given-names></name></person-group> (<year>2010</year>). <source>Chem. Pharm. Res</source>., <volume>2</volume>(<issue>2</issue>), <fpage>350</fpage>&#x2013;<lpage>356</lpage>.</citation></ref>
<ref id="bib022"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Shrikrishna</surname><given-names>B.</given-names></name><name><surname>Baokar</surname><given-names>B.</given-names></name><name><surname>Shirke</surname><given-names>V.</given-names></name><name><surname>Sivanand</surname><given-names>G.K.</given-names></name></person-group> (<year>2011</year>). <article-title>Pratheesh, Analytical Method Development and Validation for Esteemation of Sildenafil Citrate From Tablet Dosage Form by RP-HPLC</article-title>. <source>Int. J. Res. Phar.Sci</source>. <volume>2</volume>(<issue>2</issue>), <fpage>130</fpage>&#x2013;<lpage>136</lpage>.</citation></ref>
<ref id="bib023"><citation citation-type="other"><collab>The United States Pharmacopeia (USP 35)</collab>. (<year>2012</year>). <source>The National Formulary (NF 30)</source>, <fpage>5994</fpage>.</citation></ref>
<ref id="bib024"><citation citation-type="journal"><collab>Toxi-News</collab>. (<year>1999</year>). <article-title>Sildenafil (Viagra&#x00D2;)</article-title>. <source>TOXI-LAB, Irvine, CA</source>, <volume>18</volume>(<issue>1</issue>), <fpage>1</fpage>.</citation></ref>
<ref id="bib025"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Vessman</surname><given-names>J.</given-names></name></person-group> (<year>1996</year>). <article-title>Selectivity or Specificity? Validation of Analytical Methods from the Perspective of an Analytical Chemist in the Pharmaceutical Industry</article-title>. <source>J. Pharm and Biomed. Anal</source>., <volume>14</volume>, <fpage>867</fpage>&#x2013;<lpage>869</lpage>.</citation></ref>
</ref-list>
</back>
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