RP-HPLC Method for Quantification of Emtricitabine and Tenofovir Alafenamide Fumarate Drug Substance and Tablet Dosage Form

Aim: The primary objective of the research work is to develop a effective, sensitive, economical and simple reverse phase HPLC method to estimate Emtricitabine and tenofovir alafenamide fumarate in its pure and binary mixture of tablets.

Study Design: HPLC based Quantification Studies.

Place and Duration of Study: 1Department of Chemistry, Acharya Nagarjuna University,Guntur, Andhra Pradesh between April 2019 and August 2020.

Methodology: Separation of the analytes were done by using Eclipse XDB-Phenyl (250 x 4.6mm, 5µ,100 A0) column and a mobile phase ratio of 30:10:70 percentage of 0.1% trifluoro acetic acid: acetonitile: methanol at a flow rate of 1 ml/min. The injected standard and sample solutions were detected 260nm wavelength.

Results: The retention time of Emtricitabine and tenofovir alafenamide fumarate were found at 2.3min and 2.8 min respectively. The method has good linearity range about 50 to 150µg/ml of Emtricitabine and 6.5 to 19.5 µg/ml of tenofovir alafenamide fumarate. The method has validated as per ICH guidelines and all the validation parameterwere satisfy the ICH Q2 specification acceptance limits

Conclusion: The developed method said to be highly sensitive, accurate, specific and robust, therefore this method has high probability to adopt in pharmaceutical industry for regular analysis of Emtricitabine and tenofovir alafenamide.