Development and validation of an HPLC method for AG331 bulk drug substance and lyophilized powder for injection

Development and validation of an HPLC method for AG331 bulk drug substance and lyophilized powder for injection
29 June 2004
Received 25 October 2002; accepted 7 January 2004. Available online 19 May 2004.
Wen-Chin Tsai, , a, Terry L. Wilke, a, 1 and Praveen Tyle
Journal of Pharmaceutical and Biomedical Analysis
Volume 35, Issue 4 , 29 June 2004, Pages 697-702
ScienceDirect
a Pfizer Global Research and Development, La Jolla Laboratories, 4245 Sorrento Valley Blvd, San Diego, CA 92121, USA
b Pharmacia Corporation, 7000 Portage Road, Kalamazoo, MI 49001, USA
Abstract
AG331 is a water soluble glucuronate salt of a novel antitumor compound synthesized by protein structure based drug design. A lyophilized powder for injection was developed for clinical studies. During HPLC assay development, AG331 showed an inherent tailing problem due to an amino group in the structure. An optimized reverse-phase gradient HPLC method was developed to minimize the tailing and separate AG331 from its synthetic intermediates (I-1, I-2, I-3, I-4, I-5, I-6, I-8), other impurities and degradation compounds. The method was shown to be linear, precise, accurate, rugged and stability-indicating.
Author Keywords: AG331; Method development; Method validation; Lyophilized powder for injection formulation
You can view the abstract online. A subscription is required to view the full text.