UPLC Method Development And Validation For The Simultaneous Estimation Of Cytarabine And Daunorubicin In Pharmaceutical Dosage Form

Abstract

Objective: A modest, specific and reliable method UPLC method was developed for the simultaneous estimation of Cytarabine and Daunorubicin in bulk and Pharmaceutical dosage form.

Method: An ultra-performance liquid chromatographic technique has been developed to separate Cytarabine and Daunorubicin. This can be achieved by Leapsil C 18 column (Dikma) (4.6 x 50 mm, 2.7μm) using mobile phase of 0.05M Phosphate Buffer pH 3: Methanol: Acetonitrile; 40:30:30 v/v. The detector wavelength was set at 240nm. The flow rate was maintained at 0.4 ml/min, with 4 µL injection volume.

Results: The optimum concentrations of Cytarabine and Daunorubicin were found to be 37.5μg/mL and 16.5μg/mL. The mean retention time was found to be 0.842 and 0.492 min correspondingly. Linearity studies were carried out and the linear response (r2 = 0.999) was observed in the range of 12.5 - 62.5 μg/mL for Cytarabine and 5.5 – 27.5 μg/mL for Daunorubicin. The % RSD values of method precision were found to be 0.10163 and 0.10168 respectively. The accuracy of the method was performed by recovery studies. The percentage recovery was found to be in the range of 99.95–100.466 % for Cytarabine and 99.89 - 100.206 % for Daunorubicin respectively.

Conclusion: The proposed method was validated in terms of Linearity, Range, Precision, Accuracy, Specificity, LOD, LOQ and Robustness. The method was successfully applied to the estimation of Cytarabine and Daunorubicin Pharmaceutical dosage form.