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Application of Stability Indicating HPLC Method with UV Detector to the Analysis of Rivaroxaban in Bulk and Tablet Dosage Form

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1TitleTitle of DocumentApplication of Stability Indicating HPLC Method with UV Detector to the Analysis of Rivaroxaban in Bulk and Tablet Dosage Form
2CreatorAuthor's name, affiliation, country BURLA SUNITHA VENKATA SESHAMAMBA*, PERURI VEERA VENKATA SATYANARAYANA and CHANDRA BALA SEKARAN
Department of Food Chemistry and Nutrition, College of Food Science and Technology, Bapatla, Andhra Pradesh-522101, India
Department of Biochemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh-522510, India
Department of Biotechnology, Jagarlamudi Kuppuswamy Choudary College, Guntur, Andhra Pradesh-520010, India
3SubjectDicipline(s) Chemical Science
3SubjectKeywords Analysis, HPLC, Rivaroxaban, Stability indicating, Tablets
4DescriptionAbstract A simple and sensitive stability indicating HPLC method is developed for the quantification of rivaroxaban in bulk and tablet dosage form. Chromatographic separation was achieved on an ACE-Ciano column (250 mm x 4.6 mm, 5 μm particle size). The mobile phase consists of 0.1 M sodium acetate and methanol (60:40 v/v) and was delivered at a flow rate of 1 mL/min. A UV detector was used for the detection. The rivaroxaban was subjected to stress conditions for the assessment of the stability-indicating nature of the method. The method was validated as per ICH guidelines. The linearity is obtained in the range of 1-120 μg/mL. The limit of detection and quantification values is 0.194 μg/mL and 0.648 μg/mL respectively. The intra and inter-day %RSD values were below 1%. Intra and inter-day accuracies were within 100.10% and 100.40%, respectively. Degradation products resulting from the stress studies have no interfere with the detection of rivaroxaban. The average recovery of rivaroxaban in tablet dosage form was 99.74% with %RSD of 0.421%. The developed method was proved adequate for quantitative determination of rivaroxiban in presence of its degradation products.
5PublishersOrganizing agency, location WWW Publications, India
6Contributor Sponsor(s) -
7DateDate (YYYY-MM-DD) -
8TypeStatus & genre Peer-reviewed Article
8TypeType
9FormateFile Formate PDF
10IdentifierUniform Resource Identifier Click Here
10IdentifierDigital Object Identifier DOI:10.7598/cst2014.893
11SourceJournal/conference title; vol., no. (Year)Chemical Science Transactions, Volume  3 , Number  (4), (2014)
12LanuguageEnglish=en en
13RelationSupp.files
14Coverage -
15CopyrightCopyright and permissions
Chemical Science Transactions | Chem Sci Trans | CST | Online Chemistry Journal | Open Access
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