VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

This paper describes a new validated Reverse-Phase High-Performance Liquid Chromatography (HPLC) method for the simultaneous determination of two anti-cancer drugs, Daunorubicin and Cytarabine (Ara-C). A simultaneous determination method saves cost and time as both drugs can be injected into a single HPLC system without the need to change or re-equilibrate with a new mobile phase. The objective of the study is to develop a simultaneous determination method of two anti-cancer drugs, Daunorubicin and Cytarabine. The mobile phase consists of a mixture (55:45 v/v) of 0.1% OPA: acetonitrile at a flow rate of 0.8 ml/min, with a PDA detector at 240 nm. Separation was achieved on a kromosil C-18 column (5 µm; 250 mm × 4.6 mm) maintained at 30 °C temperature in a column oven. The method was linear between 7.25 µg/mL – 43.5 µg/mL for Daunorubicin and 16.2 µg/Ml – 97.5 µg/mL for Cytarabine. The limit of detection was 0.29 µg/mL for Daunorubicin, and 1.15 µg/mL for Cytarabine and the limit of quantification was 0.88 µg/mL for Daunorubicin and 3.47 µg/mL for Cytarabine. The developed RP-HPLC method achieved good precision and accuracy. The developed and validated method was suitable to be used for routine analysis of Daunorubicin and Cytarabine.