A novel rp- hplc method development & validation for simultaneous estimation of emtricitabine and tenofovir alafenamide in active pharmaceutical ingredients and marketed combined tablet dosage forms

Authors

  • Begari Lal Kumar Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Gunthapally, Hyderabad, Telangana, India.
  • K. Balaji Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Gunthapally, Hyderabad, Telangana, India.
  • Ramya Sri. S Sura Pharma Labs, Dilsukhnagar, Hyderabad, Telangana-500060, India

DOI:

https://doi.org/10.61096/ijpar.v10.iss2.2021.90-100

Keywords:

Emtricitabine, Tenofovir Alafenamide, RP-HPLC, Accuracy, Precision, ICH Guidelines.

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Emtricitabine and Tenofovir Alafenamide, in its pure form as well as in tablet dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5µ column using a mixture of Methanol: Phosphate Buffer pH3 (60:40v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 252nm. The retention time of the Emtricitabine and Tenofovir Alafenamide was 2.6, 3.8±0.02min respectively. The method produces linear responses in the concentration range of 5-25µg/ml of Emtricitabine and 20-100µg/ml of Tenofovir Alafenamide respectively. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Downloads

Published

2022-08-25

How to Cite

Begari Lal Kumar, K. Balaji, & Ramya Sri. S. (2022). A novel rp- hplc method development & validation for simultaneous estimation of emtricitabine and tenofovir alafenamide in active pharmaceutical ingredients and marketed combined tablet dosage forms. IJPAR JOURNAL, 10(2), 90–100. https://doi.org/10.61096/ijpar.v10.iss2.2021.90-100

Issue

Vol. 10 No. 2 (2021): 2021 Volume - 10 Issue - 2

Section

Articles