Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP – HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN SYNTHETIC MIXTURE

*Rajvanshi Kushagra

ABSTRACT

A simple, precise, specific, accurate and robust RP-HPLC method has been developed & validated as per ICH guideline Q2 R(1) for the simultaneous determination of Cytarabine and Daunorubicin. Chromatographic separation of these two drugs were carried out on C18 column of Inertsil (150mm x 4.6mm x 3.4μm) as stationary phase with a mobile phase consisting of Methanol:phosphate Buffer (3pH) (60:40%v/v) at a flow rate of 1mL/min and UV detection at 238 nm. The retention time of Cytarabine and Daunorubicin were 2.306 min and 4.342 min respectively. The proposed method was validated for specificity, linearity, accuracy, precision, LOD & LOQ. The describe method was linear over a concentration range of 5-15 μg/mL & 2.2 – 6.6 μg/mL for Cytarabine and Daunorubicin respectively. The % recoveries of Cytarabine and Daunorubicin were found 100.29% - 102.23% and 98.62% - 102.59%. respectively. The optimized and validated method can be used for estimation of Cytarabine and Daunorubicin in bulk and also in Synthetic mixture.

Keywords: Cytarabine, Daunorubicin, RP-HPLC, Validation, Synthetic mixture.