Method development and validation of simultaneous estimation of emtricitabine and tenofovir alafenamide in bulk and tablet dosage form using LC-MS/MS Srivastava B., Sheeja V.K*, Dr. Haribabu Y., Ebin C.J Department of Pharmaceutical Analysis, Grace College of Pharmacy, Palakkad, Kerala, 678004, India *Corresponding Author E-mail: sheejasureshsree@yahoo.com
Online published on 25 August, 2021. Abstract A selective, sensitive, rugged and high throughput high performance liquid chromatography tandem mass spectrometric method was developed for the simultaneous estimation of Emtricitabine and Tenofovir Alafenamide in Bulk and Tablet Dosage form. Liquid chromatography system has been coupled with tandem quadrupole mass spectroscopy with LC-20AD pump, electrospray ionization (ESI) interface, PDA detector (SPD-M20), column oven (CTO-20AC), CEM-20 alite controller and SIL-20AC auto sampler. Lab solution data station software was used. The separation of both Tenofovir and Emtricitabine was achieved by Gemini Cis column (4.6*100mm, 5μm) as a stationary phase with 0.1% formic acid: methanol at the ratio of 20:80, v/v at a flow rate of 0.5ml/min and injection volume of 10 μl. The percentage Recovery of the Drug Tenofovir Alafenamide and Emtricitabine was 96.59 and 96.84% respectively. The linearity range was 20–120 ng/ml for both the drugs and the LOD was found to be 5 and 10 ng/ml and LOQ were 15 and 20 ng/ml for Tenofovir and Emtricitabine Respectively. The developed method was precise, accurate, sensitive and can be used for the routine quality control of the drug formulation. Top Keywords Tenofovir alafenamide, Emtricitabine, Liquid chromatography, Mass spectroscopy, LC-MS/MS, Antiviral, Analytical Technique. Top |