A Stability Indicating RP- HPLC Method for Determination of Anticancer Agents Cytarabine in Lyophilized Dosage Form
More details
Hide details
Venus Remedies Limited, Chandigarh, India
Anuj Bhatnagar   

Venus Remedies Limited, Chandigarh, India
Publication date: 2017-11-02
Eurasian J Anal Chem 2012;7(3):160–167
An isocratic High performance liquid chromatographic method with UV detection at 280nm is described for the determination of cytarabine in finished dosage form. Cytarabine peak was obtained on a HC-C18(2) column with dimension 250mm × 4.6mm, 5μm using mobile phase contained Acetonitrile and purified water with previously adjusted pH 2.8 with orthophosphoric acid (2: 98 v/v), was delivered at flow rate of 0.7 mL per minute. The literature revealed number of reported method cytarabine alone or combination with other drug, but no stability indicating method was reported for cytarabine. The degradation study was conducted on finished dosage form of cytrabine. The cytrabine was exposed to thermal, photolytic, oxidative, acid-base hydrolysis stress condition. The degradation behaviour was observed that significant degradation under hydrogen peroxide but its value was found within specification. Under other the influences of UV light, thermal, Acidic and Alkaline conditions, there was not any significant difference. The developed Performance Liquid Chromatographic method offers stability indicating assay method as well as peak purity, symmetric peak shape, good resolution and reasonable retention time for the drug. Linearity, accuracy and precision were found to be acceptable over the concentration range of 25-150 ppm. The described LC method can be used for the quality control of formulated products containing Cytarabine.
Capizzi R L, Cheng Y C ( 1982) Sequential high-dose cytosine arabinose and asparaginase in refractory acute leukemia. Medical and Pediatriatic Oncology. 10:221-228.
Hunter T, Franke B (1975) In vitro polyoma DNA synthesis: inhibition by 1-β-darabinofuranosyl CTP. J. Virol 4:759-775.
Joseph N M, Sharma P K (2007) Cross-linked nanoparticles of cytarabine: encapsulation, storage and in-vitro release. Afr J. pharm.and pharmacol. 1:10-13.
Marchenko S, Trukhacheva T, Gubina. L, Moiseev D, Petrov P, Zhebentyaev(2006) A HPLC-based quality control of cytarabine preparations. Pharm. Chem. J. 40: 678-682.
Sun Y, Sun J, Wen B, Shi S, Xu Y, Chen Y, Wang Y, Pan C, Zhang C, Zhang T, He Z (2008) High-performance liquid chromatography/tandem mass spectrometry method for the simultaneous determination of cytarabine and its valyl prodrug valcytarabine in rat plasma. J. Chromatogr B Analyt Technol Biomed Life Sci. 870:121-125.
Hsieh Y, Li F, Duncan C J (2007) Supercritical fluid chromatography and highperformance liquid chromatography/tandem mass spectrometric methods for the determination of cytarabine in mouse plasma. Anal Chem. 79:856-861.
Hsieh Y, Duncan C J, Brisson J M (2007) Porous graphitic carbon chromatography/tandem mass spectrometric determination of cytarabine in mouse plasma. Rapid Commun Mass Spectrom. 21:629-34.
Hsieh Y, Duncan C J (2007) An ion-pairing liquid chromatography/tandem mass spectrometric method for the determination of cytarabine in mouse plasma. Rapid Commun Mass Spectrom. 21:573-578.