A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms

Abstract

Clofarabine is an anti-cancer drug. A new stability indicating isocratic RP-HPLC and LC-APCI-MS methods have been developed and validated for the quantification of Clofarabine as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A mixture of 0.1% Formic acid: Acetonitrile was used as mobile phase on gradient mode and a mixture of Methanol: Water (50:50, v/v) was used as diluent. A wide linearity concentration range 5.0-150 μg/mL was shown by the proposed method. The proposed methods are simple, precise, and accurate are used to quantify the marketed formulations of Clofarabine. Stress degradation studies were performed and the method is found to be selective and specific.