DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR TENOFOVIR SOLID LIPID NANOPARTICLESAbstract
Tenofovirdisoproxilfumarate (TDF) is an essential component of highly active antiretroviral therapy (HAART) for HIV infection used in the treatment of human immunodeficiency virus (HIV) Type-1 patients. A stability-indicating HPLC method for the determination of TDF in solid-lipid nanoparticles was developed and validated. Chromatographic analysis was performed in a Agilent 1260 Infinity series, equipped with Waters Reliant™ C18 column, (USA) (250mm long, 4.6mm internal diameter, particle size 5µm), using a mobile phase composed of an aqueous phase (20mM KH2PO4) pH 2.4 and acetonitrile in the (50:50) ratio, at 1.0ml/min flow rate and injection volume of 20μl. Under the conditions established, the method demonstrated to be specific, without interference from formulation excipients, stability- indicating, linear (r2 = 0.9977) in the concentration range of 10.0 to 60.0μg/ml, precise (RSD=0.462), accurate (99.12%-100.76% of mean recovery) and robust. The TDF sample showed degradation under acid, base, oxidative, photolytic and dry heat stress conditions. The drug content of the solid lipid nanoparticle formulation when analyzed by the proposed method was found to be 98.92%.
Vasanti M. Suvarna and Preeti C. Sangave *
Department of Pharmaceutical Chemistry, Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM’s NMIMS, Vile Parle (West) Mumbai, Maharashtra, India.
30 July, 2016
04 October, 2016
19 October, 2016
01 February, 2017