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Muralikrishna, K. S.
- Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk
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PDF Views:3
Authors
Affiliations
1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, IN
1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 3, No 2 (2013), Pagination: 62-65Abstract
A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18(250×4.6 mm, 5μm),100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r2= 0.99995). Intraday system and method precision were determined and accuracy was 99.89 %. The method was found to be robust and suitable for assay of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the assay is thus stability-indicating.Keywords
Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Acid Degradation
References
- "Xarelto: Summary of Product Characteristics". Bayer Schering Pharma AG. 2008.
- "FDA Approves XARELTO (Rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery". Janssen Pharmaceutica.
- "Bayer's Xarelto Approved in Canada" (Press release). Bayer.
- "Bayer’s Novel Anticoagulant Xarelto now also Approved in the EU". Bayer.
- ”Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)- 2-oxo-3- [4-(3- oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5- yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor"., Roehrig S, Straub A, Pohlmann J, et al, Journal of Medicinal Chemistry 48 (19): 5900–8.
- European Medicines agency (2008). “ CHP Assessment Report for Xarelto”.
- Center for drug evaluation and research and Clinical pharmacology and biopharmaceutics review(s) of Rivaroxaban
- P.V.V. Satyanarayana, Alavala Siva Madhavi, Department of Chemistry. New Spectrophotometric methods for the quantitative estimation of Rivaroxaban in formulations, International Journal of Research and Reviews in Pharmacy and Applied Science, 611-620.
- Job Harenberg, Roland Krämer, Christina Giese, Svetlana Marx, Christel Weiss, and Martin Wehling. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability, Journal of Thrombosis and Thrombolysis, J Thromb Thrombolysis.; 32(3): 267–271, October 2011.
- P.V.V Satyanarayana and Alavala Siva Madhavi. RP-HPLC method development and validation for the analyisis of rivaroxaban in pharmaceutical dosage forms 2012, 2 (1), 226-231
- Rohde G., Determination of rivaroxaban--a novel, oral, direct Factor Xa inhibitor--in human plasma by high-performance liquid chromatography-tandem mass spectrometry in Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences [2008, 872(1-2):43-50]
- Monika Bakshi and Saranjit Singh. Development of validated stability indicating assay method-critical review. J.Pharm Biomed.Anal.2002;28(6):1011-1040.
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech 2000; 24: 1-14.
- Shah BP, Jain S, Prajapati KK and Mansuri NY: Stability Indicating HPLC Method Development: A Review. Int J Pharm Res Sci. 3(9); 2978-2988
- ICH. Guidance for Industry.Q1A Stability Testing of New Drug Substances and Products. ICH-Q1A. 2001.
- ICH guidelines Q1A (R2). Stability Testing of New Drug Substances and Products (revision 2), November 2003.
- WHO, Guidelines for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional Dosage Forms, in WHO Expert Committee on Specifications for Pharmaceutical Preparations. Technical Report Series 863, World Health Organization, Geneva, 1996, pp. 65– 79.
- Vitthal V. Chopade. Sensitive Analytical Methods for Determination of Stability of Drugs in Pharmaceutical Dosage Forms. Pharma Infonet. 2008.
- 19.Q2R1 ICH guidelines for analytical method development. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guidel ine.pdf
- Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form
Abstract Views :2451 |
PDF Views:3
Authors
Affiliations
1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, IN
1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 3, No 3 (2013), Pagination: 75-78Abstract
Rivaroxaban, anti-coagulant is a novel drug for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery and no dissolution study for its estimation has been reported yet. The aim of this work was to develop and validate a dissolution profile for Rivaroxaban in a tablet dosage form using RP-HPLC method. The conditions established for dissolution were: 900 mL of acetate buffer pH=4.5 + 0.2 % sodium lauryl sulphate (SLS) as dissolution medium, using a paddle type dissolution apparatus at a stirring rate of 75 rpm which was able to give % drug release of 98.86% . The drug release was evaluated by RP-HPLC method at 250 nm and a good linearity was observed in the concentration range of 20-60 μg/mL with correlation coefficient of 0.9989. The percentage recovery of Rivaroxaban was found to be 99.63 and % CV (0.22 %; n=6) indicated a good precision of the analytical method.. Robustness of the method was performed by using different rotation speeds and Temperatures. The validation parameters included linearity, accuracy, precision and robustness. Analytical method validation was found to be within the acceptance criteria of the guidelines of ICH Q2 R1, FDA and FIP. The proposed method can be applied for routine quality control analysis of RivaroxabanKeywords
Rivaroxaban, Validation, Dissolution Apparatus,RP-HPLC Method, 250 nmReferences
- "Xarelto: Summary of Product Characteristics". Bayer Schering Pharma AG. 2008.
- "FDA Approves XARELTO (Rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery". Janssen Pharmaceutica.
- "Bayer's Xarelto Approved in Canada" (Press release). Bayer.
- "Bayer’s Novel Anticoagulant Xarelto now also Approved in the EU". Bayer.
- ”Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)- 2- oxo-3- [4-(3- oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5- yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor"., Roehrig S, Straub A, Pohlmann J, et al, Journal of Medicinal Chemistry 48 (19): 5900–8.
- Center for drug evaluation and research and Clinical pharmacology and biopharmaceutics review(s) of Rivaroxaban
- P.V.V. Satyanarayana, Alavala Siva Madhavi, Department of Chemistry. New Spectrophotometric methods for the quantitative estimation of Rivaroxaban in formulations, International Journal of Research and Reviews in Pharmacy and Applied science, 611-620.
- Job Harenberg, Roland Kramer, Christina Giese, Svetlana Marx, Christel Weiss, and Martin Wehling. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability, Journal of Thrombosis and Thrombolysis, J Thromb Thrombolysis.; 32(3): 267–271, October 2011.
- P.V.V Satyanarayana and Alavala Siva Madhavi. RP-HPLC method development and validation for the analysis of rivaroxaban in p
- harmaceutical dosage forms, 2 (1), 226-231,2012.
- Rohde G., Determination of rivaroxaban--a novel, oral, direct Factor Xa inhibitor--in human plasma by high-performance liquid chromatography-tandem mass spectrometry in Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences 872(1-2):43-50, 2008.
- Shah VP, Lesko LJ, Fan, Fleischer, J, N, J. Handerson, Malinowski, H, Makary, M, Ouderkirk, L, Roy, S, Sathe, P, Singh, GJP, Tillman, L, Tsong Y, Williams, RL., Dissolution Technol, 4(1997).
- Moore, JW, Flanner, HH, Pharm Technol, 20(1996).
- Khan, KA, J Pharm Pharmacol, 28(1975). 27. Noory C, Tran N, Ouderkirk L, Shah V, Dissolution Technol, 7(2000).
- Q2R1 ICH guidelines for analytical method development. Available at: http://www.ich.org/fileadmin/Public_Web_Site /ICH_Products/ Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf 15 FIP guidelines for dissolution testing of solid oral products available at: http://www.fip.org /www /uploads/database_file.php?id=260 &table_id= 16. The United States Pharmacopoeia (2007) 31st Ed., Unites States Pharmacopoeial Convention, Rokville