DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENOFOVIR DISOPROXIL FUMERATE AND EFAVIRENZ IN BULK AND FORMULATIONAbstract
The objective of the present work was to develop a simple, rapid, accurate RP-HPLC method for the simultaneous estimation of Tenofovir disoproxil fumerate (TDF), Efavirenz in bulk and formulation. The chromatographic separation was achieved by isocratic mode of elution by using Agilent Zorbax Eclipse XDB C18 (150 x 4.6mm, particle size 5µm) analytical column. The mobile phase consisting of Acetonitrile and phosphate buffer (0.03M KH2PO4, pH 2.5) the ratio of 70:30v/v with 0.6 ml/min flow rate and the eluents are monitored at 255nm.The retention times were 2.44min for TDF and 5.52 min for Efavirenz. The detector response was linear for TDF between 3-18µg/ml with R2 =0.9987 and 6-36µg/ml for Efavirenz with R2=0.9982 respectively. The % relative standard deviation (%R.S.D) values were found to be <2. The method was validated by determining accuracy, precision and linearity range. The results of the proposed RP-HPLC method is precise, rapid and accurate which is useful for quantitative determination and routine analysis of Tenofovir disoproxil fumerate and Efavirenz in bulk and in formulation.
D. Sri Vidya*, Y.A. Chowdary and T.E.G.K. Murthy
Department of Pharmaceutical Analysis & Quality Assurance, Bapatla College of Pharmacy, Bapatla-522101, Andhra Pradesh, India
16 July, 2013
17 August, 2013
19 November, 2013
01 December 2013