Development of HPLC Method for Ixabepilone (Oncology Drug) in Bulk and Dosage Form: Quantification of Impurities and Forced Degradation Studies

Abstract

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.

A New Method for Quantifying Aluminum in Antiperspirant Lotion Using a Differential Refractometer and an HPLC Column Containing a Maleate Functional Group Kumarswamy Ummiti1*, Narayana Reddy Godi2 , Hanimi Reddy Bapatu2

“…The utilization of stress testing can facilitate a more comprehensive comprehension of the degradation products of a medicinal product and the intrinsic stability of its molecule [13][14][15][16][17][18][19][20][21][22][23]. Therefore, both the sample and the placebo were subjected to varying levels of stress, as elaborated upon thereafter.…”