DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE AND EFAVIRENZ IN BULK AND TABLET DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2013, Vol 3, Issue 1
Abstract
ABSTRACT A simple, sensitive, rapid, economic and accurate first order derivative spectrophotometric method has been developed for estimation of Tenofovir disoproxil fumarate (TDF), Lamivudine (LAM) and Efavirenz (EFV) and in bulk and in tablet dosage form. The wavelengths selected for quantitation were 249 nm for TDF (zero cross for Lamivudine but Efavirenz shows absorbance), 293 nm for Lamivudine (zero cross for Tenofovir disoproxil fumarate and Efavirenz) and 321 nm for Efavirenz (zero cross for Tenofovir disoproxil fumarate and Lamivudine). Beer’s law was obeyed in the concentration range of 5-30 μg/ ml, 5-30 μg/ ml and 10-60 μg/ ml for TDF, LAM and EFV. The methods were validated as per ICH guidelines. Statistical analysis proved that the methods were accurate, precise, and reproducible for analysis of TDF, LAM and EFV in tablet dosage form. The wide linearity range, sensitivity, accuracy and simple procedure imply that the proposed technique demonstrated to be appropriate for routine analysis and quality control assay of tablet. Keywords: Tenofovir disoproxil fumarate, Efavirenz, Lamivudine, First Order Derivative Spectroscopy.
Authors and Affiliations
Murugan S*, Pranabesh Sikdar, Subhashis Debnath, Niranjan Babu M
Keywords
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- EP ID EP164578
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