Stability Indicating RP-HPLC Method for the Estimation of Clofarabine in Parenteral Formulation

A Simple, accurate and precise Stability Indicating RP-HPLC method was developed for estimation of Clofarabine in Parenteral Formulation. Inertial C18 (150mm×4.6mm) 5µ (particle size) was used as stationary phase. The mobile phase used was Buffer: Acetonitrile 90:10 v/v. The mobile phase was delivered at flow rate 1.0 ml/min. UV detection was set at 263nm. The retention time of Clofarabine was found to be 3.07 minutes. Linearity was observed over the concentration range of 5-25µg/ml for Clofarabine. Force degradation study was performing and maximum degradation of Standard and Test of Clofarabine was found to be 18.8% and 17.5% in Acidic condition. The LOD was found to be 0.071 µg/ml for Clofarabine. Whereas LOQ was found to be 0.21 µg/ml. Moreover, the % RSD for repeatability, inter and intraday precision was found to be less than 2%, which reveals that the method is precise.  However, the change in flow rate and mobile phase ratio also did not show any significant variance. Assay of the dosage form finalized the applicability of this method for estimation of Clofarabine in Parenteral Formulation. Keywords: RP-HPLC method, Clofarabine, ICH, LOQ, Linearity.