A Stability Indicating Method for estimating Emtricitabine and Tenofovir disoproxil fumarate simultaneously in Bulk and Combined dosage form by RP-HPLC Shaheen Rubi1,*, Rizwan S. H.2 1PG Student, Department of Pharmaceutical Analysis, Deccan School of Pharmacy, Hyderabad, Telangana, India 2Professor, Department of Pharmaceutical Analysis, Deccan School of Pharmacy, Hyderabad, Telangana, India *Corresponding Author E-mail: rubishaheen18@gmail.com
Online published on 10 August, 2020. Abstract Emtricitabine and Tenofovir disoproxil fumarate simultaneously estimated in bulk and combined dosage form by high performance liquid chromatography (HPLC) which is simple, specific, accurate and economical method. Separation using this method was achieved on a phenomenex C18 (50mm x 2.1mm ID) 1.8μm, using mobile phase sodium phosphate: acetonitrile: methanol at a ratio of 50:30:20 eluted at a flow rate of 1 ml/min. The retention time for Emtricitabine and Tenofovir disoproxil fumarate is found to be 2.3 min and 3.5 min. Quantitation was achieve with photo diode array detector at wavelength of 270 nm based on peak area with the linear calibration curve at concentration of 50–150 μg/ml for emtricitabine and 25–75 μg/ml for Tenofovir disoproxil fumarate. % Recovery was found to be 101.9% and 100.5%. The LOD were found to be 0.795 μg/ml and 2.4 μg/ml and LOQ was found to be 2.4 μg/ml for Emtricitabine and 7.0 μg/ml for Tenofovir disoproxil fumarate. The above drug combination is subjected to hydrolytic, photolytic and thermal stress environment. It was observed that Emtricitabine mostly degrade under dry heat (thermal degradation) where as Tenofovir disoproxil fumarate degrades mostly when subjected to peroxide degradation. The method was found to be specific and can be employed for the routine quality control analysis of both the drugs individually and in combined dosage form. Top Keywords Emtricitabine, Tenofovir disoproxil fumarate, Stability studies, HPLC. Top |