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Paper Title: Development and application of Liquid Chromatographic method for determination of Clofarabine in bulk and in parentral dosage forms
Authors Name: Dr.L.Satyanarayana , Dr.Sumalatha. Reddi
Unique Id: IJRTI1803004
Published In: Volume 3 Issue 3, March-2018
Abstract: Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed in the U.S. and Canada as Clolar. In Europe and Australia/New Zealand the product is marketed under the name Evoltra. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other types of treatment have failed. It is not known if the drug extends life expectancy. Some investigations of effectiveness in cases of acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) have been carried out. Developing a accurate and precise alytical method for the estimation of Clofarabine in a sterile, product for intravenous (IV) infusion a is very challenging, due to the formation of drug-drug and drug-excipient interactions. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single HPLC method for the quantitative determination of antifungal agents in freeze dried powder for injection pharmaceutical dosage form. Chromatographic separation active pharmaceutical ingredient was achieved by using a isocratic elution at a flow rate of 1.0 mL/min on Agilent Eclipse XDB Column (250mm×4.6 mm, 5μm particle size, 100Å pore size) at ambient temperature. The contents of the mobile phase were 3.48 gms of Di Potassium hydrogen ortho-phosphate (0.03M) in 1000 ml of water and by adjusting the pH to 2.5 with dilute ortho-phosphoric acid (mobile phase solvent-A) and acetonitrile (mobile phase solvent-B) in a isocratic mode in the ratio of 45:55 (v/v) of separation was used to resolute the Clofarabine. UV detection at 260 nm was employed to monitor the analytes. A linear response was observed for Clofarabine over the concentration range 2-24 μg/ mL. Limit of detection (LOD) and Limit of quantification (LOQ) for Clofarabine were found to be 0.004μg/mL, and 0.012μg/mL respectively.
Keywords: Clofarabine, Isocratic-HPLC, Casporan®, IV infusion
Cite Article: "Development and application of Liquid Chromatographic method for determination of Clofarabine in bulk and in parentral dosage forms ", International Journal of Science & Engineering Development Research (, ISSN:2455-2631, Vol.3, Issue 3, page no.19 - 25, March-2018, Available :
Downloads: 000685
Publication Details: Published Paper ID: IJRTI1803004
Registration ID:180040
Published In: Volume 3 Issue 3, March-2018
DOI (Digital Object Identifier):
ISSN Number: 2456 - 3315
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