Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Tenofovir Alafenamide Fumarate and Emtricitabine in Bulk and Tablet Dosage Form

  • Chaitali S Kalamkar Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai Phule Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India
  • Sanjay B Bhawar Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai Phule Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India

Abstract

New Analytical method was developed for the estimation of Emtricitabine and Tenofovir Alafenamide Fumarate in drug product by liquid chromatography. The chromatographic separation was achieved on Cosmosil C18 column (250mm×4.6ID, 5µm) at ambient temperature. The separation achieved employing a mobile phase consists of   Methanol:water(80:20v/v). The flow rate was 0.8ml/ minute and ultra violet detector at 252nm. The average retention time for Emtricitabine and Tenofovir Alafenamide Fumarate found to be 4.277min and 5.293min. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 10-50µg/ml for Emtricitabine and 15-75µg/ml for Tenofovir Alafenamide Fumarate. 


Keywords: Emtricitabine and Tenofovir Alafenamide Fumarate, HPLC, Methanol and validation.  



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Author Biographies

Chaitali S Kalamkar, Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai Phule Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India

Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai  Phule  Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India

Sanjay B Bhawar, Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai Phule Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India

Department of Quality Assurance, Pravara Rural College of Pharmacy, Pravaranagar, Savitribai  Phule  Pune University, Tal-Rahata, Dist-Ahmednagar, Pune, Maharashtra, India

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Kalamkar, C. S., & Bhawar, S. B. (2019). Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Tenofovir Alafenamide Fumarate and Emtricitabine in Bulk and Tablet Dosage Form. Journal of Drug Delivery and Therapeutics, 9(3-s), 243-247. https://doi.org/10.22270/jddt.v9i3-s.2832