Abstract
Objective: The novel liposomal infusion formulation of cytarabine and daunorubicin liposomal infusion is considered as new hope in acute myeloid leukemia treatment. The objective of the present study is to develop and validate a simple, rapid, accurate, precise and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of cytarabine and daunorubicin in bulk and infusion formulation.
 Methods: The chromatographic separation of the drugs was achieved on Denali C18 (250 mm×4.6 mm, 5 μm) in isocratic mode with mobile phase consisting of water (pH was adjusted to 3):acetonitrile in the ratio of 55:45 with a flow rate of 1 ml/min at a detection wavelength of 240 nm using photodiode array (PDA) detector. The column temperature was set at 30°C with 10 μl injection volume. The proposed method was validated as per the International council for Harmonisation (ICH) guidelines.
 Results: The retention times for cytarabine and daunorubicin were found to be 2.323±0.12 min and 3.140±0.16 min, respectively. Linearity (r2=0.999) was observed over a concentration range of 16.2–97.5 μg/ml for cytarabine and 7.2–43.5 μg/ml for daunorubicin. The percentage relative standard deviation (RSD) for precision studies was found to be 0.2 for both the drugs.
 Conclusion: A simple, rapid, economic, accurate, and precise RP-HPLC method was developed for simultaneous quantitative estimation of cytarabine and daunorubicin, and the method was validated as per the ICH guidelines. Hence, the method can be employed for the routine analysis of cytarabine and daunorubicin in bulk and infusion formulation.
Highlights
Cytarabine (Fig. 1) is a pyrimidine nucleoside analog used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia, acute myelogenous leukemia, and meningeal leukemia
Chemicals and reagents Pharmaceutical grade cytarabine and daunorubicin were provided as gift samples by Spectrum Pharma Research Solutions, Hyderabad, and the marketed formulation is available as Vyxeos liposome for injection, for intravenous use
Chromatographic conditions The developed method used a reverse-phase octadecyl column, Denali C18 (250 mm×4.6 mm, 5 μm), with a mobile phase consisting of water:acetonitrile (55:45) which was pumped at a flow rate of 1.0 ml/min and a detection wavelength of 240 nm using photodiode array (PDA) detector
Summary
Cytarabine (Fig. 1) is a pyrimidine nucleoside analog used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia, acute myelogenous leukemia, and meningeal leukemia. Daunorubicin (Fig. 2) is an anthracycline antibiotic that has antineoplastic activity and is used for the treatment of acute leukemia and acquired immune deficiency syndrome-related Kaposi sarcoma. It is one among six Topo II inhibitors which is prescribed as highly antineoplastic drug in clinical use [2]
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