Asian Journal of Research in Pharmaceutical Sciences

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The Estimation of Darunavir in Tablet Dosage form By RP-HPLC


Affiliations
1 Department of Pharmaceutical Chemistry, Omega College of Pharmacy, Edulabad, Ghatkesar, Ranga Reddy Dist., Hyderabad-500 034, India
2 Centre for Biotechnology, Department of Chemical Engineering, College of Engineering (A), Andhra University, Vishakapatnam - 530003, India
     

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A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Darunavir in tablet dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5m partical size, with mobile phase consisting of 0.02M Dipotassium hydrogen orthophosphate +0.02M Potassium Dihydrogen orthophosphatein in water and Acetonitrile in the ratio of 40:60 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 265 nm. The retention time was 5.859 min. The detector response was linear in the concentration of 80-240μg/ml. The respective linear regression equation being Y= 44076.08X +726603. The limit of detection and limit of quantification was 0.1μg and 0.3μg/ml respectively. The percentage assay of Darunavir was 98.58%. The method was validated by determining its accuracy, precision and system suitability.

The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Darunavir in bulk drug and in its pharmaceutical dosage form.


Keywords

Darunavir, RP-HPLC, Estimation, and Tablets.
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  • The Estimation of Darunavir in Tablet Dosage form By RP-HPLC

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Authors

L. Satyanarayana
Department of Pharmaceutical Chemistry, Omega College of Pharmacy, Edulabad, Ghatkesar, Ranga Reddy Dist., Hyderabad-500 034, India
S. V. Naidu
Centre for Biotechnology, Department of Chemical Engineering, College of Engineering (A), Andhra University, Vishakapatnam - 530003, India
M. Narasimha Rao
Centre for Biotechnology, Department of Chemical Engineering, College of Engineering (A), Andhra University, Vishakapatnam - 530003, India
Alok Kumar
Department of Pharmaceutical Chemistry, Omega College of Pharmacy, Edulabad, Ghatkesar, Ranga Reddy Dist., Hyderabad-500 034, India
K. Suresh
Department of Pharmaceutical Chemistry, Omega College of Pharmacy, Edulabad, Ghatkesar, Ranga Reddy Dist., Hyderabad-500 034, India

Abstract


A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Darunavir in tablet dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5m partical size, with mobile phase consisting of 0.02M Dipotassium hydrogen orthophosphate +0.02M Potassium Dihydrogen orthophosphatein in water and Acetonitrile in the ratio of 40:60 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 265 nm. The retention time was 5.859 min. The detector response was linear in the concentration of 80-240μg/ml. The respective linear regression equation being Y= 44076.08X +726603. The limit of detection and limit of quantification was 0.1μg and 0.3μg/ml respectively. The percentage assay of Darunavir was 98.58%. The method was validated by determining its accuracy, precision and system suitability.

The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Darunavir in bulk drug and in its pharmaceutical dosage form.


Keywords


Darunavir, RP-HPLC, Estimation, and Tablets.