title: Spectrophotometric simultaneous determination of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form by ratio derivative, first order derivative and absorbance corrected methods and its application to dissolution study.
abstract: Three simple, economical, precise, and accurate methods are described for the simultaneous determination of Tenofovir disoproxil fumarate (TE) and Emtricitabine (EM) in combined tablet dosage form. The first method is ratio derivative spectra, second is first-order derivative spectrophotometry and third is absorption corrected method. The amplitudes at 271.07 and 302.17 nm in the ratio derivative method, 224.38 and 306.88 nm in the first order derivative method were selected to determine Tenofovir disoproxil fumarate (TE) and Emtricitabine (EM), respectively, in combined formulation. Beer's law is obeyed in the concentration range of 3-21 μg/ml for TE and 2-14 μg/ml for EM for first two methods and range for third method was 6-30 μg/ml of TE and 4-20 μg/ml of EM. The percent assay for commercial formulation was found to be in the range 98.91%-101.72% for both the analytes by the proposed three methods. Absorption corrected method was successfully applied to carry out dissolution study of commercial tablet formulation by using USP II dissolution test apparatus. The methods were validated with respect to linearity, precision, and accuracy. Recoveries by proposed methods were found in the range of 99.06 %-101.34 % for both the analytes.
authors.affiliation: Pharmaceutical Analysis and Quality Assurance Department, MAEER'S Maharashtra Institute of Pharmacy, MIT Campus, Pune, Maharashtra, India.
authors.forename: Vishnu P
authors.initials: VP
authors.lastname: Choudhari
authors.forename: Snehal
authors.initials: S
authors.lastname: Ingale
authors.forename: Sacchidanand R
authors.initials: SR
authors.lastname: Gite
authors.forename: Dipali D
authors.initials: DD
authors.lastname: Tajane
authors.forename: Vikram G
authors.initials: VG
authors.lastname: Modak
authors.forename: Archana
authors.initials: A
authors.lastname: Ambekar
keywords: Absorbance corrected; Emtricitabine; Tenofovir disoproxil fumarate; derivative spectrophotometry; ratio derivative spectrophotometry; tablet dosage form