RESUMO
The objective of study is to develop a new stability-indicating HPLC method for quantifying ixabepilone degradation products and known process impurities (EPO-2 and Epothilone B) in bulk and injectable dose forms. A gradient stability-indicating RP-HPLC approach was developed to determine the known impurities of ixabepilone in ixabepilone API and ixabepilone for injection. Ixabepilone was subjected to base, acid, oxidation, photolytic and thermal degradations. The gradient approach was used to optimize the mobile phase-A [pH 4.8 acetate buffer (10 mM) and acetonitrile 90:10 v/v] and mobile phase-B [pH 4.8 acetate buffer (10 mM) and acetonitrile 20:80 v/v] of a USP L1 column. A wavelength of 250 nm was chosen based on known impurities and degradation products response, with a 1.0 mL/min flow rate. In compliance with ICH criteria Q2(R1), the developed technique was validated. The stability-indicating-related impurities technique was proven to be appropriate for estimating degrading impurities and known impurities in ixabepilone API and ixabepilone injection.