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Preparation and Characterization of Four Major Novel Degradation Products of Pralatrexate Injection and Validation of HPLC-UV Method

Author(s):

Regella V.R. Prabhakara Sastry*, C. S Venkatesan, B. S. Sastry, S. Sathiyanarayanan and Sanapati Murali   Pages 1 - 13 ( 13 )

Abstract:


Background: Four major degradation products (1-4) of pralatrexate injection were formed under hydrolytic and light stress conditions. The impurities 1 and 2 were the potential photo degradation products and the impurities 3 and 4 were the potential hydrolytic degradation products.

Objective: To prepare and characterize the novel degradation impurities 1, 2, 3 and 4 of pralatrexate injection using NMR, HR MS and IR techniques; and to develop and validate stability indicating analytical reverse phase HPLC-UV method for quantitative simultaneous determination of potential degradation impurities, related substances of pralatrexate and pralatrexate active in pralatrexate liquid formulation.

Method: Gradient HPLC-UV method was developed for the quantification of degradation impurities, related substances and pralatrexate in pralatrexate injection. The separation was achieved on C18 column (250 mm X 4.6 mm, 5

Keywords:

Pralatrexate, Stress conditions, Degradation products, Characterization, Gradient HPLC-UV, Validation, Stabilityindicating method.

Affiliation:

Gland Pharma Ltd., R&D, D.P.Pally, Gandimaisamma X roads, Gland Pharma Ltd., R&D, D.P.Pally, Gandimaisamma X roads, Gland Pharma Ltd., R&D, D.P.Pally, Gandimaisamma X roads, Gland Pharma Ltd., R&D, D.P.Pally, Gandimaisamma X roads, Gland Pharma Ltd., R&D, D.P.Pally, Gandimaisamma X roads



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