Abstract
AimA simple, accurate, precise and rapid HPTLC methods for simultaneous determination of Tenofovir disoproxil fumarate (TDF) and emtricitabine (ETB) in combined dosage forms. MethodThe method is based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 276 nm. The separation was carried out on Merck TLC aluminium sheets of silica gel 60F 254 using toluene: ethyl acetate: methanol: acetic acid (6: 4: 3:0.4, v/v/v) as a mobile phase. Stability of TDF and ETB was carried out by forced degradation study. ResultTDF and ETB gave sharp and well defined peak at Rf 0.41 and 0.68, respectively. Calibration curves were linear in range 150–1500 ng/spot and 100–1000 ng/spot for TDF and ETB, respectively. Method was successively applied to tablet formulation. Stability study shows that the chromatograms of samples degraded with acid, base, hydrogen peroxide and light showed well separated spots of pure TDF and ETB as well as some additional peaks at different Rf values. ConclusionThe method is successively applied to pharmaceutical formulation; No chromatographic interferences from the tablet excipients were found. The suitability of this HPTLC method for quantitative determination of the compounds is proved by validation in accordance with the requirements of ICH guidelines.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
