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Rapid Stability Indicating RP-HPLC Method for Simultaneous Quantification of Related Impurities of Antiretroviral Drugs
Corresponding Author(s) : M. Himaja
Asian Journal of Chemistry,
Vol. 27 No. 7 (2015): Vol 27 Issue 7, 2015
Abstract
A simple, rapid and stability indicating reverse phase liquid chromatographic method has been developed for the simultaneous quantitative determination of emtricitabine, rilpivirine and tenofovir disoproxil fumarate and their related impurities in a combined dosage form. The pharmaceutical formulation along with individual active ingredients were subjected to stress conditions of hydrolysis (acid and base), oxidation and thermal degradation as per ICH guidelines. The chromatographic separation was achieved using an Xterra RP C18 (250 × 4.6 mm, 5 μm stationary phase with a linear gradient elution and the detection wavelength was set at 254 nm. The mobile phase consists of buffer and acetonitrile delivered at a flow rate of 1 mL/min. The stress samples were assayed against a reference standard and the mass balance was found to be close to 99 %. The proposed RP-HPLC method was validated with respect to linearity, precision, accuracy and robustness.
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- A. Rouzes, K. Berthoin, F. Xuereb, S. Djabarouti, I. Pellegrin, J. Pellegrin, A. Coupet, S. Augagneur, H. Budzinski and M. Saux, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 813, 209 (2004); doi:10.1016/j.jchromb.2004.09.041.
- M.R. Induri, M.B. Raju, Y.R. Prasad, K.P.K. Reddy and C.H.S. Raidu, Indian J. Pharm. Educ. Res, 45, 305 (2011).
- S. Raffanti and D. Haas, Antimicrobial Agents: Anti-Retroviral Agents, McGraw-Hill, New York (1990).
- N.L. Rezk, R.D. Crutchley and A.D.M. Kashuba, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 822, 201 (2005); doi:10.1016/j.jchromb.2005.06.019.
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- A.A. Shirkhedkar and B.C.H. Surana, Pak. J. Pharm. Sci., 22, 27 (2009).
- R.W. Sparidans, K.M. Crommentuyn, J.H. Schellens and J.H. Beijnen, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 791, 227 (2003); doi:10.1016/S1570-0232(03)00225-3.
- K. Mangaonkar and A. Desai, Indian Drugs, 45, 119 (2008).
- R. Sharma and K. Mehta, Indian J. Pharm. Sci., 72, 527 (2010); doi:10.4103/0250-474X.73926.
- J.M. Molina, P. Cahn, B. Grinsztejn, A. Lazzarin, A. Mills, M. Saag, K. Supparatpinyo, S.Walmsley, H. Crauwels, L.T. Rimsky, S. Vanveggel and K. Boven, J. Lancet, 378, 238 (2011); doi:10.1016/S0140-6736(11)60936-7.
- K.Y. Kavitha, G. Geetha, R. Hariprasad, R. Venkatnarayana and G. Subramanian, Int. J. Comp. Pharm.,1, 7 (2013).
- M. Pendela, G.W. Kahsay, G.V. Mooter, L. Baert, J. Hoogmartens and E. Adams, Chromatographia, 73, 439 (2011); doi:10.1007/s10337-010-1906-1.
- ICH Guidelines: Q1AR Stability Testing of New Drug Substances and Products (2000).
References
A. Rouzes, K. Berthoin, F. Xuereb, S. Djabarouti, I. Pellegrin, J. Pellegrin, A. Coupet, S. Augagneur, H. Budzinski and M. Saux, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 813, 209 (2004); doi:10.1016/j.jchromb.2004.09.041.
M.R. Induri, M.B. Raju, Y.R. Prasad, K.P.K. Reddy and C.H.S. Raidu, Indian J. Pharm. Educ. Res, 45, 305 (2011).
S. Raffanti and D. Haas, Antimicrobial Agents: Anti-Retroviral Agents, McGraw-Hill, New York (1990).
N.L. Rezk, R.D. Crutchley and A.D.M. Kashuba, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 822, 201 (2005); doi:10.1016/j.jchromb.2005.06.019.
S. Sentenac, C. Fernandez, A. Thuillier, P. Lechat and G. Aymard, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 793, 317 (2003); doi:10.1016/S1570-0232(03)00333-7.
A.A. Shirkhedkar and B.C.H. Surana, Pak. J. Pharm. Sci., 22, 27 (2009).
R.W. Sparidans, K.M. Crommentuyn, J.H. Schellens and J.H. Beijnen, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 791, 227 (2003); doi:10.1016/S1570-0232(03)00225-3.
K. Mangaonkar and A. Desai, Indian Drugs, 45, 119 (2008).
R. Sharma and K. Mehta, Indian J. Pharm. Sci., 72, 527 (2010); doi:10.4103/0250-474X.73926.
J.M. Molina, P. Cahn, B. Grinsztejn, A. Lazzarin, A. Mills, M. Saag, K. Supparatpinyo, S.Walmsley, H. Crauwels, L.T. Rimsky, S. Vanveggel and K. Boven, J. Lancet, 378, 238 (2011); doi:10.1016/S0140-6736(11)60936-7.
K.Y. Kavitha, G. Geetha, R. Hariprasad, R. Venkatnarayana and G. Subramanian, Int. J. Comp. Pharm.,1, 7 (2013).
M. Pendela, G.W. Kahsay, G.V. Mooter, L. Baert, J. Hoogmartens and E. Adams, Chromatographia, 73, 439 (2011); doi:10.1007/s10337-010-1906-1.
ICH Guidelines: Q1AR Stability Testing of New Drug Substances and Products (2000).