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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   4

Issue No. :  10

Year :  2011

Pages :   1626-1629

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Validated RP-HPLC Method Development for Estimation of Tenofovir Disoproxil Fumarate from Plasma



Address:   Shubhangi V. Sutar1*, Harinath N. More1, Sachin A. Pishawikar1, Sandip A. Bandgar2 and Indrayani D. Raut3
1Bharathi Vidyapeeth College of Pharmacy, Kolhapur.
2Ashokrao Mane College of Pharmacy, Peth-vadgaon.
3Rajarambapu College of Pharmacy, Kasegaon.
*Corresponding Author
DOI No: Not Available

ABSTRACT:
Tenofovir Disoproxil Fumarate, a diester prodrug of Tenofovir, is a nucleotide reverse transcriptase inhibitor. After oral absorption, Tenofovir Disoproxil Fumarate is rapidly converted to tenofovir and then undergoes subsequent phosphorylation by cellular enzymes to the active Tenofovir Diphosphate, which inhibits the activity of HIV-1 reverse transcriptase. There are very few methods for analysis of degradation products and impurities of Tenofovir Disoproxil Fumarate have been reported. The present work based on development of suitable, specific and sensitive analytical method. Here we have developed a precise, accurate, simple, reliable and less time consuming RP-HPLC method for estimation of this drug from plasma. The result for precision was R.S.D. = 20% at LLOQ and R.S.D. = 15% other than LLOQ. This shows that the method is accurate and precise. Result of short term stability study performed by thawing samples at low and high concentration for 6 hours and % stability calculated which is between 85-115%. Extraction recovery was determined by spiking the pure drug sample in previously analyzed sample which is more than 50 %.
KEYWORDS:
RP-HPLC with UV detector, Tenofovir Disoproxil Fumarate, Extraction recovery, Short term stability study.
Cite:
Shubhangi V. Sutar, Harinath N. More, Sachin A. Pishawikar, Sandip A. Bandgar, Indrayani D. Raut. Validated RP-HPLC Method Development for Estimation of Tenofovir Disoproxil Fumarate from Plasma. Research J. Pharm. and Tech. 4(10): Oct. 2011; Page 1626-1629.
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