Asian Journal of Pharmaceutical Analysis

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Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form


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1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India
     

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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 Rivaroxaban

Keywords

Rivaroxaban, Validation, Dissolution Apparatus,RP-HPLC Method, 250 nm
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  • Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form

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Authors

Pinaz A. Kasad
Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India
K. S. Muralikrishna
Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India

Abstract


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 Rivaroxaban

Keywords


Rivaroxaban, Validation, Dissolution Apparatus,RP-HPLC Method, 250 nm

References