Hussen, Syed Sajjad and Dengale, Swapnil J and Udupa, N and Krishna, Muddu (2013) Development and validation of HPLC method for tenofovir in small volumes of rat plasma using SPE and application to pharmacokinetic studies. Journal of Pharmacy and Phytotherapeutics, 1 (5). pp. 14-20.

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Abstract

A simple, cost effective HPLC-UV method for estimation of Tenofovir (TNF) in rat plasma was developed and validated as per the US-FDA guidelines. The chromatographic separation was achieved using a Lichrocart C18 (250 × 4.6 mm inner diameter × 5-μm particle size) column with mobile phase comprising of Acetonitrile and potassium dihydrogen buffer containing tert butyl-amine as an ion pair reagent (53:47 %v/v), delivered isocratically at a flow rate of 1.0 mL min-1. Paracetamol was used as an IS. Cation exchange solid phase extraction was employed for sample clean up from rat plasma. The chromatographic peak-area ratio, based on UV absorbency at 260 nm, was used for quantitative analysis. The statistical evaluation of the method was examined and the method was found to be precise and accurate with a linearity range of 10–600 ngmL-1 (r > 0.9980). The intra-day and inter-day precision expressed as the percentage coefficient of variation (%CV) for the method were below 5.80 and 6.57% respectively. The recoveries for TNF ranged from 97.96% to 81.24%. The assay was applied successfully to evaluate the difference in the pharmacokinetics of TNF pure drug and developed nano-formulation.

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