Selective RP-HPLC DAD method for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets

• Autorzy: Abdelhay M. H , Gazy A. A , Shaalan R. A , Ashour H. K
• Języki publikacji: EN

Abstrakty

EN

A simple and selective liquid chromatographic method was developed for the simultaneous determination of tenofovir disoproxil fumarate (TEN) and emtricitabine (EMT) in combined tablets. The method is based on separation of TEN and EMT on a Zorbax SB-C8 column, 5 μm, 4.6 × 250 mm, with a mobile phase consisting of 50 mM disodium hydrogen phosphate-acetonitrile (50:50, v/v). The mobile phase contains 0.1% triethylamine (TEA) and was adjusted to pH 6.0. Quantification of the analytes is achieved with diode array — ultraviolet detector (DAD-UV) at 260 and 280 nm for TEN and EMT, respectively, based on peak area. Different variables affecting the method were carefully investigated and optimized. Reliability and analytical performance of the proposed method, including linearity, range, precision, accuracy, and detection and quantitation limits, were statistically validated. The high-performance liquid chromatography (HPLC) method was successfully applied for determination of each drug in their binary tablets.

Słowa kluczowe

EN

HPLC; DAD; tenofovir; emtricitabine; tablets

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 1
• Strony: 41--54
• Opis fizyczny: Bibliogr. 46 poz., rys., tab.

Twórcy

autor

Abdelhay M. H

• University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt

autor

Gazy A. A

• University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt

autor

Shaalan R. A

• [e-mail]
• University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt

autor

Ashour H. K

• University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt

Bibliografia

• [1] S.C. Sweetman, Martindale — The Complete Drug Reference, Vol. 1, 36th edn, The Pharmaceutical Press, London, UK, 2009
• [2] A.R. Gennaro, Remington — The Science and Practice of Pharmacy, 21st edn, Lippincott Williams & Wilkins, Baltimore, USA
• [3] A.C. Moffat, M.D. Osselton, and B. Widdop, Clark’s Analysis of Drugs and Poisons, Vol. 2, 3rd edn., The Pharmaceutical Press, London, UK, 2004
• [4] M.C. Sharma, S. Sharma, and A.D. Sharma, J. Chem. Pharm. Res., 2, 411–415 (2010)
• [5] G. Gnanarajan, A.K. Gupta, V. Juyal, P. Kumar, P.K. Yadav, and P. Kailash, J. Young Pharm., 1, 351–353 (2009)
• [6] A.A. Shirkhedkar, C.H. Bhirud, and S.J. Surana, Pak. J. Pharm. Sci., 22, 27–29 (2009)
• [7] A.A. Shirkhedkar, C.H. Bhirud, and S.J. Surana, Res. J. Chem. Environ., 12, 49–50 (2008)
• [8] A.A. Shirkhedkar, C.H. Bhirud, and S.J. Surana, Orient. J. Chem., 23, 1115–1118 (2007)
• [9] P.K. Vanitha, M. Padmalatha, and E. Dopadally, Biosci., Biotechnol. Res. Asia, 7, 445–448 (2010)
• [10] S.M. Mallipatil, S. Noola, M.A. Nandedkar, P.S. Sarsambi, and A. Sonawane, Int. J. Chem. Sci., 8, 977–982 (2010)
• [11] M. Majumder, B. Gopinath, G. Koni, and S.K. Singh, E-J. Chem., 6, 537–540 (2009)
• [12] N.A. Raju, J.V. Rao, K.V. Prakash, and K. Mukkanti, Biosci., Biotechnol. Res. Asia, 5, 439–442 (2008)
• [13] S.O. Choi, N. Rezk, J.S. Kim, and A.D.M. Kashuba, J. Chromatogr. Sci., 48, 219–223 (2010)
• [14] M. Yadav, T. Mishra, P. Singhal, S. Goswami, and P.S. Shrivastav, J. Chromatogr. Sci., 47, 140–148 (2009)
• [15] P.B. Kandagal, D.H. Manjunatha, J. Seetharamappa, and S.S. Kalanur, Anal. Lett., 41, 561–570 (2008)
• [16] M. Takahashi, Y. Kudaka, N. Okumura, A. Hirano, K. Banno, and T. Kaneda, Biol. Pharm. Bull., 30, 1784–1786 (2007)
• [17] C. Bennetto-Hood, M.C. Long, and E.P. Acosta, Rapid Commun. Mass Spectrom., 21, 2087–2094 (2007)
• [18] T. King, L. Bushman, J. Kiser, P.L. Anderson, M. Ray, T. Delahunty, and C.V. Fletcher, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 843, 147–156 (2006)
• [19] T. Delahunty, L. Bushman, and C.V. Fletcher, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 830, 6–12 (2006)
• [20] D. Ashenafi, V. Chintam, D. van Veghel, S. Dragovic, J. Hoogmartens, and E. Adams, J. Sep. Sci., 33, 1708–1716 (2010)
• [21] Z. Ahmed, S.K. Shetty, B. Gopinath, M. Ahmed, and B.K. Sridhar, Int. J. Chem. Sci., 7, 2447–2458 (2009)
• [22] S.M. Malipatil and M.A. Nandedkar, J. Indian Counc. Chem., 26, 67–69 (2009)
• [23] N. Stefania, B. Alessio, I. Giuseppe, N. Pasquale, P.P. Leopoldo, T. Gianna, P.D. Raffaele, G. Francesco, and A. Paolo, J. Chromatogr., B, 831, 258–266 (2006)
• [24] A. Peepliwal and C.G. Bonde1, J. Pharm. Res., 3, 1712–1715 (2010)
• [25] J.A.H. Droste, R.E. Aarnoutse, and D.M. Burger, J. Liq. Chromatogr. Relat. Technol., 30, 2769–2778 (2007)
• [26] H. Rebiere, B. Mazela, C. Civadea, and P. Bonneta, J. Chromatogr., B, 850, 376–383 (2007)
• [27] M. Pendelaa, D.A. Mamadea, J. Hoogmartensa, A. Van Schepdaela, and E. Adams, Talanta, 82, 125–128 (2010)
• [28] D. Ashenafi, A. Verbeek, J. Hoogmartens, and E. Adams, J. Sep. Sci., 32, 1823–1830 (2009)
• [29] U. Seshachalam, B. Haribabu, and K.B. Chandrasekhar, J. Sep. Sci., 30, 999–1004 (2007)
• [30] V.R. Robledoa and W.F. Smythb, Anal. Chimi. Acta, 623, 221–230 (2008).
• [31] N.L. Rezk, R.D. Crutchley, and A.D.M. Kashuba, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 822, 201–208 (2005)
• [32] N.A. Gomes, V.V. Vaidya, A. Pudage, S.S. Joshi, and S.A. Parekh, J. Pharm. Biomed. Anal., 48, 918–926 (2008)
• [33] A. Karunakaran, K. Kamarajan, and V. Thangarasu, Pharm. Sin., 1, 52–60 (2010)
• [34] R. Sharma and P. Gupta, Eurasian J. Anal. Chem., 4, 276–284 (2009)
• [35] T. Delahunty, L. Bushman, B. Robbins, and C.V. Fletcher, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 877, 1907–1914 (2009)
• [36] A. D’Avolio, M. Sciandra, M. Siccardi, L. Baietto, D. Gonzalez de Requena, S. Bonora, and G. Di Perri, J. Chromatogr. Sci., 46, 524–528 (2008)
• [37] K.D. Ingale, A.L. Barhate, A.N. Kale, C.D. Bobade, V.P. Choudhari, and B.S. Kuchekar, J. Pharm. Res., 9, 11–13 (2010)
• [38] S.A. Ghorpade, M.S. Sali, A.H. Kategaonkar, D.M. Patel, V.P. Choudhari, and B.S. Kuchekar, J. Chil. Chem. Soc., 55, 115–117 (2010)
• [39] J. Maithilee, A.P. Nikalje, M. Shahed, M. Dehghan, and Y.B. Chavan, Indian J. Pharm. Sci., 71, 95 (2009)
• [40] M. Yadav, P. Singhal, S. Goswami, U.C. Pande, M. Sanyal, and P.S. Shrivastav, J. Chromatogr. Sci., 48, 704–713 (2010)
• [41] T. Le Saux, S. Chhun, E. Rey, O. Launay, L. Weiss, J. Viard, G. Pons, and V. Jullien, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 865, 81–90 (2008)
• [42] A. Senthilkumar, V. Shankarananth, K.K. Rajasekhar, K.S. Srinivas, R. Manikandan, and G. Kumar, J. Pharm. Res., 2, 1601–1605 (2009)
• [43] http://www.gilead.com/pdf/truvada_au_pi.pdf (through internet search on 1st November 2010)
• [44] The British Pharmacopoeia, Her Majesty’s Stationery Office, London, 2010
• [45] ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures, Text and Methodology, Q2(R1), International Conference on Harmonisation, Geneva, 2005
• [46] S.A. Ghorpade, M.S. Sali, A.H. Kategaonkar, D.M. Patel, V.P. Choudhari, and B.S. Kuchekar, J. Chil. Chem. Soc., 55, 115–117 (2010)