J. Pharm. Technol. Res. Manag.

A Precise Review on Tenofovir Disoproxil Fumarate: An Analytical Profile

Vinod A. Chaure; Saurabh B. Ganorkar; Ganesh U. Chaturbhuj; Sanjay J. Surana and Atul A. Shirkhedkar

KEYWORDS

Tenofovir Disoproxil Fumarate; Review Article; Validation; HPLC; HPTLC

PUBLISHED DATE Nov. 2, 2018
PUBLISHER The Author(s) 2018. This article is published with open access at www.chitkara.edu.in/publications.
ABSTRACT

Tenofovir Disoproxil Fumarate (TDF) is antiretroviral medicine used treat AIDS as well as chronic Hepatitis-B. TDF is a prodrug of tenofovir and exists as dominant form due to lesser oral bioavailability of parent drug. TDF is now available in a fixed-dose combination with various antiretrovirals like Cobicistat, Efavirenz, Elvitegravir, Emtricitabine, Lamivudine, Rilpivirine, and Nevirapine. Hence, pharmaceutical analysis of TDF and applicability of different analytical methods have gained crucial importance. The present review article assesses the published analytical methods and a variety of approach for investigation of TDF in bulk drug as well as pharmaceutical formulations including combinations. This detailed review includes examination of around eighty analytical methods published during 2008 to 2016 using various techniques which include HPLC, HPTLC, and UV/ Visible-Spectrophotometry. The review also illustrates the scope and limitations of many published analytical methods for analysis of TDF. Such detailed review will be of great help to the researcher who is working on TDF. Miscellaneous methods of rare but unique pharmaceutical distinction have also been given due consideration. The diagrammatic illustrations provide the statistical overview about the various methods referred for analysis of TDF.

INTRODUCTION

Tenofovir Disoproxil Fumarate (TDF) Fig. 1 is an antiretroviral medicine used to treat HIV/AIDS and chronic hepatitis B [1]. TDF is a prodrug of Tenofovir (TNF) and exists as dominant form due to low oral bioavailability of TNF. The active substance TNF inhibits the Nucleotide Reverse Transcriptase. TDF is quickly hydrolysed into Tenofovir monophosphate in the body and gets converted into the active drug. The chemical reaction for this conversion in vivo is as represented in Fig. 2[2]. TDF is available in the market as tablets; alone and in combination with other drugs. TDF is mostly expelled with Glomerular filtration and in that being transported into renal proximal tubule cells through organic anion transporter-1 (OAT-1). TDF usually considered as a safe drug, but renal toxicities are reported with its use. The reports are available which provides cause of proximal tubulopathy of kidney, Fanconi syndrome, kidney related other toxicities including insipidus calcium and phosphorus dysregulation with bone disease and reduction in Glomerular function [3]. Besides the aforementioned effects, the antiretroviral therapy (ART) has transformed HIV infection into a manageable, lifelong disease. The first line regimens are critical to successful ART for its long-term treatment [4].

Page(s) 153-167
URL Jaswinderpal Singh 12:48 PM (2 hours ago) to me http://dspace.chitkara.edu.in/jspui/bitstream/123456789/788/1/JPTRM%206-2-1.pdf http://dspace.chitkara.edu.in/jspui/bitstream/123456789/789/1/JPTRM%206-2-2.pdf http://dspace.chitkara.edu.in/jspui/bitstream/123456789/790/1/JPTRM%206-2-3.pdf http://dspace.chitkara.edu.in/jspui/bitstream/123456789/791/1/JPTRM%206-2-4.pdf http://dspace.chitkara.edu.in/jspui/bitstream/123456789/792/1/JPTRM%206-2-5.pdf http://dspace.chitkara.edu.in/jspui/bitstre
ISSN Print : 2321-2217, Online : 2321-2225
DOI 10.15415/jptrm.2018.62012
CONCLUSION

Review of literature reported during the period of 2008 -2016 described analytical methods for estimation of TDF. Different analytical methods implemented for analysis of TDF in bulk and in its combined dosage forms and in plasma include LC-MS/MS, HPLC, HPTLC and UVSpectroscopy methods. Fig. 2 depicts method prevalence for pharmaceutical analysis of TDF and Fig. 3 give comparative account on various methods published using different analytical techniques for TDF.

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