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Area Under Curve Spectrophotometric Method for Determination of Rivaroxaban in Bulk and Tablet Formulation and Its Validation


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

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The present research work discusses the development of an Area under the Curve spectrophotometric method for Rivaroxaban. Simple, sensitive, reproducible, accurate, rapid, simple and cost efficient spectrophotometric method has been developed for the estimation of Rivaroxaban in bulk and dosage form. The optimum conditions for the analysis of the drug were established. The study was conducted in Methanol between the wavelengths of 241nm- 260 nm. The method validations was accomplished through evaluation of analytical parameters of linearity, range, accuracy and precision, limit of detection and limit of quantification and robustness as per ICH guidelines. The developed method was linear (r2= 0.999) in the concentration range of 2-12 μg/ml, precise (Mean %RSD inter day is 0.537 and Mean %RSD intraday is 0.297), accurate (% recovery= 99.31%) and sensitive (LOD and LOQ of 0.059 and 0.179 μg/ml respectively). The proposed method is observed to be suitable for the analysis of Rivaroxaban in bulk and Dosage form for quality control purposes.

Keywords

Rivaroxaban, Oral Anticoagulant, AUC Method, Validation.
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  • Area Under Curve Spectrophotometric Method for Determination of Rivaroxaban in Bulk and Tablet Formulation and Its Validation

Abstract Views: 66  |  PDF Views: 2

Authors

A. Kasad Pinaz
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


The present research work discusses the development of an Area under the Curve spectrophotometric method for Rivaroxaban. Simple, sensitive, reproducible, accurate, rapid, simple and cost efficient spectrophotometric method has been developed for the estimation of Rivaroxaban in bulk and dosage form. The optimum conditions for the analysis of the drug were established. The study was conducted in Methanol between the wavelengths of 241nm- 260 nm. The method validations was accomplished through evaluation of analytical parameters of linearity, range, accuracy and precision, limit of detection and limit of quantification and robustness as per ICH guidelines. The developed method was linear (r2= 0.999) in the concentration range of 2-12 μg/ml, precise (Mean %RSD inter day is 0.537 and Mean %RSD intraday is 0.297), accurate (% recovery= 99.31%) and sensitive (LOD and LOQ of 0.059 and 0.179 μg/ml respectively). The proposed method is observed to be suitable for the analysis of Rivaroxaban in bulk and Dosage form for quality control purposes.

Keywords


Rivaroxaban, Oral Anticoagulant, AUC Method, Validation.