STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE

The main objective of the study was to develop an RP-UPLC method for the simultaneous determination and validation of the Daunorubicin and Cytarabine in the pharmaceutical dosage form. The technique was developed by using the Mobile phase containing Buffer 0.01N KH₂PO₄: Acetonitrile used in the ratio 50:50 v/v and X-Bridge C18 (2.1 × 100 mm, 1.6 µm) as a stationary phase at a flow rate of 0.3 ml/min. The buffer used in this method was 0.01N KH₂PO₄ (3.5 pH) buffer pH was accustomed by means of the solution of 0.1% OPA. The temperature was maintained throughout the method at 30°C, and the optimized wavelength chosen was 240.0 nm. The technique was developed and thoroughly validated based on the ICH (International Conference on Harmonization) guidelines. The validation process was done by precision, linearity, robustness studies, accuracy, Limit of Detection, Limit of quantification, and degradation studies. The robustness studies were observed by making variations in the mobile phase, temperature, and flow rate. The accuracy was observed at more than 96% recovery. The stability of drug samples was showed more than 98% recovery over different environmental and laboratory circumstances. The LOD and the LOQ values were within limits. The developed RP-UPLC method achieved good precision and accuracy. The developed and validated method was suitable for the analysis of Daunorubicin and Cytarabine.