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This work is licensed under a Creative Commons Attribution 4.0 International License.
RP-HPLC Method for Estimation of Ado-Trastuzumabe Emtansine Injection in Pharmaceutical Dosage Form
Corresponding Author(s) : Lakshmi Kanta Kanthal
Asian Journal of Chemistry,
Vol. 30 No. 2 (2018): Vol 30 Issue 2
Abstract
The aim of the present work is to develop and validate a simple, reliable and accurate method for ado-trastuzumab emtansine in pharmaceutical dosage form by reverse phase HPLC method. The proposed RP-HPLC (reverse phase-high performance liquid chromatography) method utilized a WATERS HPLC (model-Agilent 2695), C18 RP Column (150 mm × 4.6 mm × 5 μm) in separation mode with mobile phase consisting of 0.1 M potassium dihydrogen phosphate (KH2PO4) and methanol in the ratio of 55: 45 % (v/v), at a flow rate 1.1 mL/min and the effluent was monitored at 242 nm. The retention time of ado-trastuzumabe emtansine was 3.2 min. The method was linear in range of 50 to 150 μg and the correlation coefficient was 0.999. The percentage recovery was 100 %. LOD (limit of detection) and LOQ (limit of quantitation) for this method were found to be 0.236 and 0.787, respectively. The present method is very simple, sensitive and accurate procedure for estimation of ado-trastuzumabe emtansine.
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- J.M. Lambert and R.V.J. Chari, J. Med. Chem., 57, 6949 (2014); https://doi.org/10.1021/jm500766w.
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- H.M. Lamb and J.C. Adkins, Drugs, 56, 1125 (1998); https://doi.org/10.2165/00003495-199856060-00020.
- N.H. Foda and O.M.A. Gohary, Anal. Lett., 27, 2523 (1994); https://doi.org/10.1080/00032719408002659.
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References
J.M. Lambert and R.V.J. Chari, J. Med. Chem., 57, 6949 (2014); https://doi.org/10.1021/jm500766w.
P.F. Peddi and S.A. Hurvitz, Ther. Adv. Med. Oncol., 6, 202 (2014); https://doi.org/10.1177/1758834014539183.
G.D. Lewis Phillips, G. Li, D.L. Dugger, L.M. Crocker, K.L. Parsons, E. Mai, W.A. Blattler, J.M. Lambert, R.V.J. Chari, R.J. Lutz, W.L.T. Wong, F.S. Jacobson, H. Koeppen, R.H. Schwall, S.R. Kenkare-Mitra, S.D. Spencer and M.X. Sliwkowski, Cancer Res., 68, 9280 (2008); https://doi.org/10.1158/0008-5472.CAN-08-1776.
J.R. Junutula, H. Raab, S. Clark, S. Bhakta, D.D. Leipold, S. Weir, Y. Chen, M. Simpson, S.P. Tsai, M.S. Dennis, Y. Lu, Y.G. Meng, C. Ng, J. Yang, C.C. Lee, E. Duenas, J. Gorrell, V. Katta, A. Kim, K. McDorman, K. Flagella, R. Venook, S. Ross, S.D. Spencer, W. Lee Wong, H.B. Lowman, R. Vandlen, M.X. Sliwkowski, R.H. Scheller, P. Polakis and W. Mallet, Nat. Biotechnol., 26, 925 (2008); https://doi.org/10.1038/nbt.1480.
H.M. Lamb and J.C. Adkins, Drugs, 56, 1125 (1998); https://doi.org/10.2165/00003495-199856060-00020.
N.H. Foda and O.M.A. Gohary, Anal. Lett., 27, 2523 (1994); https://doi.org/10.1080/00032719408002659.
N. Mondal, T.K. Pal and S.K. Ghosal, Pharmazie, 62, 597 (2007); https://doi.org/10.1691/ph.2007.8.6305.
V.P. Shah, K.K. Midha, S. Dighe, I.J. McGilveray, J.P. Skelly, A. Yacobi, T. Layloff, C.T. Viswanathan, C.E. Cook, R.D. McDowall, K.A. Pittman, S. Spector, K.S. Albert, S. Bolton, C.E. Cook, S. Dighe, M. Dobrinska, W. Doub, M. Eichelbaum, J.W.A. Findlay, K. Gallicano, W. Garland, D.J. Hardy, J.D. Hulse, H.T. Karnes, R.D. McDowall, R. Lange, T. Layloff, W.D. Mason, G. McKay, I.J. McGilveray, K.K. Midha, E. Ormsby, J. Overpeck, K.A. Pittman, H.D. Plattenberg, V.P. Shah, G. Shiu, D. Sitar, J.P. Skelly, F. Sorgel, S. Spector, J.T. Stewart, C.T. Viswanathan,A. Yacobi and L. Yuh, Int. J. Pharm., 82, 1 (1992); https://doi.org/10.1016/0378-5173(92)90065-A.
T.K. Mandal,A. Mishra, W.R. Singh, G. Dewangan and S. Hazra, J. Adv. Pharm. Technol. Res., 5, 147 (2014); https://doi.org/10.4103/2231-4040.137448.