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A New Gradient Liquid Chromatographic Method for Simultaneous Estimation of Tenofovir Disoproxil Fumarate, Cobicistat, Emtricitabine and Elvitegravir in Bulk Drug and Tablet Dosage Form
Corresponding Author(s) : V.V. Raveendra Babu
Asian Journal of Chemistry,
Vol. 26 No. 18 (2014): Vol 26 Issue 18
Abstract
A new gradient reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous estimation of tenofovir disoproxil fumarate, cobicistat, emtricitabine and elvitegravir. The chromatography was achieved on Hypersil BDS, C18 column, (100 × 4.6 mm, 5 m) with a mobile phase composed of phosphate buffer (pH 3) and acetonitrile taken in gradient mode at a flow rate of 0.8 mL/min. Detection was performed at 245 nm by using PDA detector. The retention times for tenofovir disoproxil fumarate, cobicistat, emtricitabine and elvitegravir were 2.1, 4.3, 5.2 and 8.5 min, respectively. This method was validated for parameters like system suitability, linearity, precision, specificity, accuracy and robustness. This method was successfully applied for the estimation of tenofovir disoproxil fumarate, cobicistat, emtricitabine and elvitegravir in bulk drug and tablet dosage form.
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- S.W. Masho, C.L. Wang and D.E. Nixon, Ther. Clin. Risk Manag., 3, 1097 (2007).
- K. Woratanarat, T. Kanjanabuch and C. Suankratay, J. Med. Assoc. Thai., 96, 432 (2013).
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- J.R. Arribas, J. Eron. Curr. Opin. HIV AIDS, 8, 341 (2013).
- J.M. Belavic, Nurse Pract., 38, 24 (2013); doi:10.1097/01.NPR.0000425824.44694.e8.
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- S. Rajesh and G.A. Pooja, Eurasian J. Anal. Chem., 4, 276 (2009).
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- P.D. Hamarapurkar and A.N. Parate, J. Chromatogr. Sci., 51, 419 (2013); doi:10.1093/chromsci/bms157.
- P. Kumar, S.C. Dwivedi and A. Kushnoor, Res. J. Chem. Sci., 1, 33 (2007).
- A.P. Nikalje, A. Maniyar and S. Obaid, Am. J. PharmTech Res., 3, 651 (2013).
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References
S.W. Masho, C.L. Wang and D.E. Nixon, Ther. Clin. Risk Manag., 3, 1097 (2007).
K. Woratanarat, T. Kanjanabuch and C. Suankratay, J. Med. Assoc. Thai., 96, 432 (2013).
Z. Temesgen, Drugs Today, 49, 233 (2013); doi:10.1358/dot.2013.49.4.1947288.
P.L. Anderson, J.J. Kiser, E.M. Gardner, J.E. Rower, A. Meditz and R.M. Grant, J. Antimicrob. Chemother., 66, 240 (2011); doi:10.1093/jac/dkq447.
Z. Temesgen, Drugs Today, 48, 765 (2012); doi:10.1358/dot.2012.48.12.1895682.
J.R. Arribas, J. Eron. Curr. Opin. HIV AIDS, 8, 341 (2013).
J.M. Belavic, Nurse Pract., 38, 24 (2013); doi:10.1097/01.NPR.0000425824.44694.e8.
A. Zolopa, P.E. Sax, E. DeJesus, A. Mills, C. Cohen, D. Wohl, J.E. Gallant, H.C. Liu, A. Plummer, K.L. White, A.K. Cheng, M.S. Rhee and J. Szwarcberg, J. Acquir. Immune Defic. Syndr., 63, 96 (2013); doi:10.1097/QAI.0b013e318289545c.
J.L. Olin, L.M. Spooner and O.M. Klibanov, Ann. Pharmacother., 46, 1671 (2012); doi:10.1345/aph.1R468.
A.A. Shirkhedkar, C.H. Bhirud and S. Sanjaja, Pak. J. Pharm. Sci., 22, 27 (2009).
G. Gnanarajan, A.K. Gupta, V.K. Juyal, P. Yadav and P. Kailash, J. Pharm Anal., 1, 351 (2009).
B. Anindita, P. Aurobinda, K.M. Amit, G.S. Dannana, K.M. Swapan and C. Sudam, Int. J. Pharm. Teach., 3, 1878 (2011).
C.M. Bhaskar Reddy and G.V. Subba Reddy., Int. Res. J. Pharm., 3, 268 (2012).
S.P. Sagar, D. Pratik and M.M. Annapurna, Int. J. Pharm. Res. Dev., 1, 1 (2009).
P.B. Kandagal, D.H. Manjunatha, J. Seetharamappa and S.S. Kalanur, Anal. Lett., 41, 561 (2008); doi:10.1080/00032710801910742.
S. Rajesh and G.A. Pooja, Eurasian J. Anal. Chem., 4, 276 (2009).
S. Padigela, V.V.S. Rajendra Prasad, M.B. Raju and N. Suresh Kumar, Am. J. Pharm. Res., 3, 4697 (2013).
P.D. Hamarapurkar and A.N. Parate, J. Chromatogr. Sci., 51, 419 (2013); doi:10.1093/chromsci/bms157.
P. Kumar, S.C. Dwivedi and A. Kushnoor, Res. J. Chem. Sci., 1, 33 (2007).
A.P. Nikalje, A. Maniyar and S. Obaid, Am. J. PharmTech Res., 3, 651 (2013).
R.K. Valluru and N.B. Kilaru, J. Chromatogr. B, 931, 117 (2013); doi:10.1016/j.jchromb.2013.05.008.
N.A. Gomes, V.V. Vaidya, A. Pudage, S.S. Joshi and S.A. Parekh, J. Pharm. Biomed. Anal., 48, 918 (2008); doi:10.1016/j.jpba.2008.07.022.
W. Kromdijk, S.A. Pereira, H. Rosing, J.W. Mulder, J.H. Beijnen and A.D. Huitema, J. Chromatogr. B, 919-920, 43 (2013); doi:10.1016/j.jchromb.2013.01.005.
S.F.L. Janice, C. Alexandra, A.M. Isabelle and F. Nathan, HIV AIDS, 4, 5 (2012).
ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1) Current Step 4 Version, November (2005).