A validated stability‐indicating reversed‐phase liquid chromatography method for the quantification of Ixabepilone (Oncology drug) in the parenteral dosage form

Abstract

AbstractA quick and simple isocratic stability indicating method has been developed for the quantification of Ixabepilone in active pharmaceutical ingredient and injection dose formulation using reversed phase‐high‐performance liquid chromatography. Based on the response of Ixabepilone and impurities, the method was developed on a Symmetry C18 (150 × 4.6) mm, 5‐micron (Waters) column. An isocratic mobile phase consisted of pH 4.7 acetate buffer (10 mM) and acetonitrile in the composition of 60:40 v/v at 1.0 ml/min flow rate with a run time of 15 min, and Ixabepilone was eluted at about retention time of 5.1 min. The developed method is validated to meet International Conference on Harmonization standards. Linearity of Ixabepilone was established for the concentration range 0.050 to 0.15 mg/ml (r2 > 0.999) with respect to working concentration 0.10 mg/ml. Recovery was established from 50% (0.050 mg/ml) to 150% (0.15 mg/ml) of the target concertation (0.10 mg/ml). Precision and Intermediate precision met the acceptance criteria as per International Conference on Harmonization Q2(R1). It was proved that the stability indicating nature for quantifying Ixabepilone in Ixabepilone active pharmaceutical ingredient and drug product. As a result, the assay of Ixabepilone can be analyzed using this method for pharmaceutical development and quality control.