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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
A. Suneetha*, V. Mounika and S. Bindu Venkata Sravani
This present work describes a new validated Reverse Phase High Performance Liquid Chromatography (HPLC) method for the simultaneous determination of anti-cancer drugs, Daunorubicin and Cytarabine. 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 estimation of two anti-cancer drugs in Pharmaceutical Dosage forms. The mobile phase consists of a mixture (50:50 v/v) of 0.1% Octane sulphonic acid: acetonitrile at a flow rate of 1 ml/min, with a PDA detector at 238 nm. Separation was achieved on a Xbridge C18 (150 x 4.6mm) maintained at 30°C temperature in a column oven. The method was linear between 22?g/ml – 110?g/ml for Daunorubicin and 50?g/ml - 250?g/ml for Cytarabine. The limit of detection was 2.98?g/ml for Daunorubicin, and 3.00?g/ml for Cytarabine and the limit of quantification was 10.00?g/mL for Daunorubicin and 9.98?g/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.[Full Text Article]