HPTLC-densitometry method development and validation for simultaneous determination of abacavir, lamivudine and zidovudine in combined dosage form

Subject Areas : Journal of the Iranian Chemical Research

Adnan A. Bekhit ¹ , Adissu Alemayehu ² , Abdel-Maaboud I. Mohamed ³ , Ariaya Hymete ⁴

1 - Department of Pharmaceutical Chemistry, School of Pharmacy, Addis Ababa University, Addis Ababa1176 Ethiopia.
2 - Department of Pharmaceutical Chemistry, School of Pharmacy, Addis Ababa University, Addis Ababa1176 Ethiopia.
3 - Department of Pharmaceutical Chemistry, School of Pharmacy, Addis Ababa University, Addis Ababa1176 Ethiopia.
4 - Department of Pharmaceutical Chemistry, School of Pharmacy, Addis Ababa University, Addis Ababa1176 Ethiopia.

Received: 2011-04-10 Accepted : 2011-10-24 Published : 2011-03-20

Keywords: Determination, Densitometry, HPTLC, Abacavir, Lamivudine, Zidovudine, Simultaneous,

Abstract :

A simple, accurate and precise HPTLC- densitometry method for the simultaneousdetermination of abacavir, lamivudine and zidovudine in pharmaceutical tablet has beendeveloped. Separation of tablet components was performed on aluminum backed HPTLC plates(silica gel 60 F254 20×20 cm with 0.2 mm thickness, Camag, Muttenz, Switzerland ) usingmethanol : chloroform : acetonitrile (4 : 8 : 3 v/v). Good sensitivity for all analytes was observedwith UV detection at 275 nm. The method was validated for linearity, accuracy, precision,specificity and robustness. The method allowed quantitation over the 200–1450 ng/band rangefor the three components. Both linear and second order polynomial relationships were studied.Second order polynomial fit was found to be more suitable and its residuals plot showed a muchbetter fitting than that of linear model, indicating good correlation and determinations (r =0.99995, 0.9998 and 0.9998 and r2 = 0.9999, 0.9997 and 0.9996 for 3-TC, ABC and AZT,respectively). The method has an accuracy of 99.35, 99.19 and 99.13 % for 3-TC, ABC and AZTrespectively. The method is robust and has the potential to determine these drug substancessimultaneously from the dosage forms.

References:

[1] E. De Clercq, Biochim. Biophys. Acta. 1587 (2002) 258-275.
[2] H.T. Nguyen, Management of HIV-1 infection in adults. Proceeding (Baylor University, Medical
Chem. Center) 22 (2009) 62–68.
[3] K.R. Eugenio, C.S. Zeind, J. Phar. Pract. 13 (2001) 426-441.
[4] H. Lüllmann, K. Mohr, A. Ziegler, D. Bieger, J. Wirth, Color atlas of pharmacology. 2nd edition,
Thieme Stuttgart, New York, 2000.
[5] E. De Clercq, Int. J. Biochem. Cell B. 36 (2004) 1800-1822.
[6] http://www.fda.gov/cder/guidance/index.htm /accessed on May 23, 2009.
[7] I. Tim, P.M. Caroline, Drugs 63 (2003) 1089-1098.
[8] G.J. Yuen, Y. Lou, N.F. Thompson, V.R. Otto, T.L. Allsup, W.B. Mahony, H.W. Hutman, J. Clin.
Pharmacol. 41 (2001) 277
[9] A. El –Gindy, A. Ahmed, A. Laila, M. Marwan, J. Pharmaceut. Biomed. Anal. 25 (2001) 171-179.
[10] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances
UCM134409.pdf /accessed on July 25, 2009.
11] E. Reich, A. Blatter, R. Jorns, M. Kreuter, K. Thiekötter, J. Plan. Chromatogr. 15 (2002) 244-251.
[12] E.S. Jovanovic, D. Agbaba, D. Zivanov-Stakic, S. Vladimirov, J. Pharmceut. Biomed. Anal. 18
(1998) 893–898.
[13] R.E. Estrela, M.C. Salvadori, G. Suarez-Kurtz, Rapid Commun. Mass Sp. 18 (2004) 1147-1155.
[14] L.D. Williams, L.S. Von Tungeln, F.A. Beland, D.R. Doerge, J. Chromatogr. B Analyt. Technol.
Biomed. Life Sci. 798 (2003) 55-62.
[15] B. Uslu, S.A. Ozkan, Anal. Chem. Acta. 466 (2002) 175-185.
[16] S.R. Lewis, C.A. White, M.G. Bartlett, J. Chromatogr. B 850 (2007) 45-52.
[17] N. Gomes, A. Pudage, S.S. Joshi, V. Vaidy, S. Parekh, Chromatographia 68 (2008) 1612-1112.
[17] Y. Alnouti, C.A. White, M.G. Bartlett, Biomed. Chromatogr. 18 (2004) 641-647.
[18] G. Habte, A. Hymete, I.M. Abdel-Maabboud, Anal. Lett. 42 (2009) 1552-1570.
[19] M.R. Moghadam, Sh. Dadfarnia, J. Ghasemi, A.M. Hajishabani, J. Iran. Chem. Res. 3 (2010) 1-9
A. Alemayehu et al. / J. Iran. Chem. Res. 4 (2011) 251-262
262
[20] A.H.M. Sarrafi, M. Bahmaei, A.Z. Mousavi, J. Iran. Chem. Res. 3 (2010) 31-36
[21] P. Djurdjevic, A. Laban, S. Markovic, M. Jelikic-Stankov, Anal. Lett. 37 (2004) 2649-2667.
[22] A. Savaser¸ S. Goraler, A. Tasoz¸ B. Uslu, H. Lingeman, S. Ozkan, Chromatographia 65 (2007) 259-
265.
[23] T. Sauxa, S. Chhuna, E. Reya, O. Launayc, L. Weissd, J. Viarde, G. Ponsa, V. Julliena, J.
Chromatogr. B 865 (2008) 81-90.
[24] B.H. Jung, N.L. Rezk, A.S. Bridges, A.H. Corbett, A.D. Kashuba, Biomed. Chromatogr. 21 (2007)
1095-1104.
[25] S. Notari, A. Bocedi, G. Ippolito, P. Narciso, L.P. Pucillo, G. Tossini, R.P. Donnorso, F. Gasparrini,
P. Ascenzi, J. Chromatogr. B 831 (2006) 258-266.
[26] S. Sathe, S. Bari, Acta Chromatogr. 19 (2007) 270–278.
[27] S. Qutab, S. Razzaq, M. Ashfaq, Z. Shuja, U. Khan, Acta Chromatogr. 19 (2007) 143-149.