Development and validation of an HPLC method for AG331 bulk drug substance and lyophilized powder for injection.
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.
Tsai
Wen-Chin
WC
Pfizer Global Research and Development, La Jolla Laboratories, 4245 Sorrento Valley Blvd, San Diego, CA 92121, USA. wen-chin.tsai@pfizer.com
Wilke
Terry L
TL
Tyle
Praveen
P
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D005612:Freeze Drying / Q000379:methods; D007211:Indoles / Q000032:analysis* / Q000737:chemistry*; D011208:Powders
D007211:Indoles; D011208:Powders; C087748:AG 331