RJPT - RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form

<!DOCTYPE html> <html> <head><meta charset="utf-8" /><meta http-equiv="X-UA-Compatible" content="IE=edge" />  <meta name="viewport" content="width=device-width, initial-scale=1" />  <title> RJPT - RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form </title><link href="css1/bootstrap.min.css" rel="stylesheet" />  <link href="fonts/css/font-awesome.min.css" rel="stylesheet" />  <link href="https://fonts.googleapis.com/css?family=Lato:400,300,400italic,700,900,700italic" rel="stylesheet" type="text/css" /><link href="https://fonts.googleapis.com/css?family=Roboto:500" rel="stylesheet" type="text/css" />  <link rel="stylesheet" href="css1/slicknav.css" />  <link href="rs-plugin/css/settings.css" rel="stylesheet" />  <link href="css1/owl.carousel.css" rel="stylesheet" />  <link href="style.css" rel="stylesheet" />  <link href="css1/responsive.css" rel="stylesheet" /><meta name="msapplication-TileColor" content="#ffffff" /><meta name="msapplication-TileImage" content="f_icon/ms-icon-144x144.png" /><meta name="theme-color" content="#ffffff" /> <script type="text/javascript" src="https://d3mkw6s8thqya7.cloudfront.net/integration-plugin.js" id="aisensy-wa-widget" widget-id="XFmHWJ" > </script> <meta name="Description" content="For the detection of Rivaroxaban in Pharmaceutical Tablet dosage form, a straightforward, rapid, highly selective, accurate, and exact reverse phase high performance liquid chromatographic (RP-HPLC) approach was designed and validated. The Adamas C8, (150 4.6mm, 5µm) column was used for the development, and the oven temperature used was 30°C. A 60:40% (v/v) combination of acetonitrile and water made up the solvent reservoir mobile phase. With a DAD detector, the flow rate was 1.0 ml per minute, and the wavelength was 253nm. The run time was limited to five minutes. Using EZ Chrome software, the separation was performed using an Agilent 1100 series HPLC. Rivaroxaban's retention period was measured at 3.680 minutes. According to ICH Q2 R1 recommendations, the method was validated in terms of parameters including linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. With a correlation coefficient of 0.9998, the linearity was in the 10–50µg/ml range. Less than 2% was discovered to be the accuracy's relative standard deviation. The average recovery rate ranged from 100.12% to 101.58%. Limits of quantification and detection were discovered to be 0.3µg/ml and 1.0µg/ml, respectively. The suggested method for determining the dosage of Rivaroxaban in tablet form was successfully established." /><meta http-equiv="Content-Type" content="text/html; charset=utf-8" /><meta name="citation_title" content="RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form" /><meta name="citation_author" content="Tushar Bhatkar" /><meta name="citation_author" content="Pramod Burakle" /><meta name="citation_author" content="Prashant Ajmire" /><meta name="citation_author" content="Rahul Jawarkar" /><meta name="citation_author" content="Pravin Khatale" /><meta name="citation_author" content="Ekant Taywade" /><meta name="citation_publication_date" content="2024/06/25" /><meta name="citation_date" content="2024/06/25" /><meta name="citation_journal_title" content="Research Journal of Pharmacy and Technology" /><meta name="citation_volume" content="17" /><meta name="citation_issue" content="6" /><meta name="citation_firstpage" content="2869" /><meta name="citation_lastpage" content="2874" /><meta name="citation_abstract_pdf_url" content="https://rjptonline.org/AbstractView.aspx?PID=2024-17-6-69" /><meta name="citation_html_url" content="https://rjptonline.org/HTMLPaper.aspx?Journal=Research Journal of Pharmacy and Technology;PID=2024-17-6-69" /><meta name="citation_abstract_html_url" content="https://rjptonline.org/AbstractView.aspx?PID=2024-17-6-69" /><meta name="citation_publisher" content="Research Journal of Pharmacy and Technology" /><meta name="citation_issn_print" content="0974-3618" /><meta name="citation_issn_online" content="0974-360X" /><meta name="citation_language" content="English" /><meta name="citation_keywords" content="Rivaroxaban; HPLC; Method validation; Tablets dosage form; Method development; ICH ; Pharmaceutical; straightforward; chromatographic; recommendations; quantification; quantification" /><meta name="citation_doi" content="10.52711/0974-360X.2024.00450" /></head> <body> <form method="post" 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" 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</div> </div> <div class="col-md-2 col-lg-2 col-sm-12 col-xs-12"> <div class="opening_time s_header"> <p class="uppercase" style="color: #1a00cc; font-size: 14px; font-weight: bold">ISSN</p> <p style="color: #1a00cc; line-height: 21px"> 0974-360X (Online) <br /> 0974-3618 (Print) </p> </div> </div> </div> </div> <br /> </div> </div>   <section class="slider_area"> <div class="mainmenu_area"> <div class="container"> <div class="row"> <div class="col-md-10 col-lg-10"> <div class="mainmenu nav"> <nav> <ul id="nav"> <li class="current"><a href="Home.aspx">Home <i class="fa fa-angle-down"></i></a> <ul> <li><a href="AboutJournal.aspx">About Journal</a></li> <li><a href="Indexed_In.aspx">Indexing Information</a></li> <li><a href="ContactUs.aspx">Raise Query</a></li> </ul> </li> <li><a href="PastIssues.aspx">Past Issues</a></li> <li><a href="EditorialBoard.aspx">Editorial Board</a></li> <li><a href="#">For Authors <i class="fa fa-angle-down"></i></a> <ul> <li><a 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class="request_code"> <a href="SubmitArticle.aspx">Submit Article</a> </div> </div> </div> </div> </div> </section>  <div class="container"> <div class="col-md-9 col-lg-9 col-sm-12 col-xs-12"> <section class="blog_area section_padding"> <div class="row"> <div class="Abstract_page_title text-center"> <h1> <span id="ContentPlaceHolder1_PaperTitle" style="font-weight:bold;"><a href='AbstractView.aspx?PID=2024-17-6-69' class='myLink'>RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form</a><a href='https://scholar.google.co.in/scholar?q=RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form' target='_blank' style='color:blue'> <img src='Images/GoogleScholar.png' style='height:23px'></a></span> </h1> </div> <div class="single_blog"> <div style="background: #f6f6f6 none repeat scroll 0 0; padding: 8px; border-left: 4px solid #11c3f1"> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Author(s):</span> <span id="ContentPlaceHolder1_AuthorName"><a href='search.aspx?key=Tushar Bhatkar' >Tushar Bhatkar</a>, <a href='search.aspx?key=Pramod Burakle' >Pramod Burakle</a>, <a href='search.aspx?key=Prashant Ajmire' >Prashant Ajmire</a>, <a href='search.aspx?key=Rahul Jawarkar' >Rahul Jawarkar</a>, <a href='search.aspx?key=Pravin Khatale' >Pravin Khatale</a>, <a href='search.aspx?key=Ekant Taywade' >Ekant Taywade</a></span> </p> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Email(s):</span> <span id="ContentPlaceHolder1_AuthorEmail"><a href='mailto:tusharbhatkar10@gmail.com' target='_blank' >tusharbhatkar10@gmail.com</a> </span> </p> <p style="text-align: left; font-size: 14px;"> <span style="color: rgba(193, 4, 4, 0.76)">DOI:</span> <span id="ContentPlaceHolder1_DOI_No" style="font-weight:normal;"><a href='https://doi.org/10.52711/0974-360X.2024.00450' target='_blank' style='color:blue'>10.52711/0974-360X.2024.00450</a>    <a href='https://scholar.google.co.in/scholar?q=10.52711/0974-360X.2024.00450' target='_blank' style='color:blue'> <img src='Images/GoogleScholar.png' style='height:25px'></a></span> </p> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Address:</span> <span id="ContentPlaceHolder1_AuthorAddress">Tushar Bhatkar1*, Pramod Burakle1, Prashant Ajmire2, Rahul Jawarkar1, Pravin Khatale1, Ekant Taywade1<br> 1Department of Pharmaceutical Chemistry, Dr. Rajendra Gode Institute of Pharmacy, Amravati – 444901.<br> 2Department of Pharmacology, Dr. Rajendra Gode Institute of Pharmacy, Amravati – 444901.<br> *Corresponding Author</span> </p> <p style="text-align: left; font-size: 13px; margin-top: 5px"> <span style="color: rgba(193, 4, 4, 0.76)">Published In:</span>   <a href="Issues.aspx?VID=17&IID=6" id="ContentPlaceHolder1_Vol_Issue_link" style="font-weight:bold">Volume - <span id="ContentPlaceHolder1_VOL_no" style="font-weight:normal;">17</span>,      Issue - <span id="ContentPlaceHolder1_ISSUE_no" style="font-weight:normal;">6</span>,     Year - <span id="ContentPlaceHolder1_Pub_Year" style="font-weight:normal;">2024</span> </a> </p> <div class="clearfix"></div> <div style="float:right;"> <span id="ContentPlaceHolder1_Cite_icon_lbl" style="font-weight:normal;"><script async src='https://badge.dimensions.ai/badge.js' charset='utf-8'></script> <span class='__dimensions_badge_embed__' data-doi='10.52711/0974-360X.2024.00450' data-style='small_circle'></span> <div class='clearfix'></div></span> </div> <div class="blog_page" style="padding: 10px; margin-bottom: 28px"> <a href="HTMLPaper.aspx?Journal=Research Journal of Pharmacy and Technology;PID=2024-17-6-69" id="ContentPlaceHolder1_HTML_View_lnk" class="top_quate_action2 float_Right"> <img src="Images/html.png" />  View HTML</a>      <a id="ContentPlaceHolder1_Subscribe_btn" class="top_quate_action2 float_Right" href="javascript:__doPostBack('ctl00$ContentPlaceHolder1$Subscribe_btn','')"><img src="Images/cart_add.png" style="height:28px" />   Purchase PDF</a> </div> <div class="clearfix"></div> </div> <div class="blog_content blog_page"> <br /> <p style="text-align: justify"> <span style="color: black; font-weight: bold">ABSTRACT:</span> <br /> <span id="ContentPlaceHolder1_Abstract" style="color:Black;">For the detection of Rivaroxaban in Pharmaceutical Tablet dosage form, a straightforward, rapid, highly selective, accurate, and exact reverse phase high performance liquid chromatographic (RP-HPLC) approach was designed and validated. The Adamas C8, (150 4.6mm, 5µm) column was used for the development, and the oven temperature used was 30°C. A 60:40% (v/v) combination of acetonitrile and water made up the solvent reservoir mobile phase. With a DAD detector, the flow rate was 1.0 ml per minute, and the wavelength was 253nm. The run time was limited to five minutes. Using EZ Chrome software, the separation was performed using an Agilent 1100 series HPLC. Rivaroxaban's retention period was measured at 3.680 minutes. According to ICH Q2 R1 recommendations, the method was validated in terms of parameters including linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. With a correlation coefficient of 0.9998, the linearity was in the 10–50µg/ml range. Less than 2% was discovered to be the accuracy's relative standard deviation. The average recovery rate ranged from 100.12% to 101.58%. Limits of quantification and detection were discovered to be 0.3µg/ml and 1.0µg/ml, respectively. The suggested method for determining the dosage of Rivaroxaban in tablet form was successfully established.</span> </p> <br /> <div class="tags"> <i class="text-left" style="color:black; font-size: 13px; font-weight: normal">Keywords:</i> <span id="ContentPlaceHolder1_Key_words" style="font-size:Smaller;"><ul class='text-left'><li><a href=''Rivaroxaban' target='_blank' >Rivaroxaban</a></li><li><a href=''HPLC' target='_blank' >HPLC</a></li><li><a href=''Method validation' target='_blank' >Method validation</a></li><li><a href=''Tablets dosage form' target='_blank' >Tablets dosage form</a></li><li><a href=''Method development' target='_blank' >Method development</a></li><li><a href=''ICH.' target='_blank' >ICH.</a></li></ul></span> </div> </div> <div class="highlight_text"> <img src="img/hilight.png" alt=""> <p> <span style="color: rgba(193, 4, 4, 0.76)">Cite this article:</span> <br /> <span id="ContentPlaceHolder1_Cite">Tushar Bhatkar, Pramod Burakle, Prashant Ajmire, Rahul Jawarkar, Pravin Khatale, Ekant Taywade. RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(6):2869-4. doi: 10.52711/0974-360X.2024.00450</span> <br /><br /> <span style="color: rgba(193, 4, 4, 0.76)">Cite(Electronic):</span> <br> <span id="ContentPlaceHolder1_Cite1">Tushar Bhatkar, Pramod Burakle, Prashant Ajmire, Rahul Jawarkar, Pravin Khatale, Ekant Taywade. RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(6):2869-4. doi: 10.52711/0974-360X.2024.00450   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-6-69</span> </p> </div> <div class="clearfix"></div> <br /> <span id="ContentPlaceHolder1_Additional_Information_lbl"><b>REFERENCES:</b><br>1.    Duggan ST. Rivaroxaban: a review of its use for the prophylaxis of venous thromboembolism after total hip or knee replacement surgery. 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RJPT - RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form