Stability Indicating RP-HPLC Method for the Estimation of Clofarabine in Parenteral Formulation
DOI:
https://doi.org/10.22270/ijmspr.v8i2.42Keywords:
RP-HPLC method, Clofarabine, ICH, LOQ, LinearityAbstract
A Simple, accurate and precise Stability Indicating RP-HPLC method was developed for estimation of Clofarabine in Parenteral Formulation. Inertial C18 (150mm×4.6mm) 5µ (particle size) was used as stationary phase. The mobile phase used was Buffer: Acetonitrile 90:10 v/v. The mobile phase was delivered at flow rate 1.0 ml/min. UV detection was set at 263nm. The retention time of Clofarabine was found to be 3.07 minutes. Linearity was observed over the concentration range of 5-25µg/ml for Clofarabine. Force degradation study was performing and maximum degradation of Standard and Test of Clofarabine was found to be 18.8% and 17.5% in Acidic condition. The LOD was found to be 0.071 µg/ml for Clofarabine. Whereas LOQ was found to be 0.21 µg/ml. Moreover, the % RSD for repeatability, inter and intraday precision was found to be less than 2%, which reveals that the method is precise. However, the change in flow rate and mobile phase ratio also did not show any significant variance. Assay of the dosage form finalized the applicability of this method for estimation of Clofarabine in Parenteral Formulation.
Keywords: RP-HPLC method, Clofarabine, ICH, LOQ, Linearity.
References
Tripathi KD., Essentials of Medical Pharmacology; 6th Edn; Jaypee Brothers Medical Publishers (P) Ltd, New Delhi,2008-09, pp 819
Malcolm R Alison, "Cancer" Imperial College School of Medicine, London, UK
Buddhini Samarasinghe, "The Hallmarks of Cancer tissue Invasion and Metastasis" Oct 30 2013
"Clolar Mechanism of Action" Sep 2015 https://www.clolar.com/Hcp-mechanism-of-action
International Conference on Harmonization, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, International Conference on Harmonisation, IFPMA, Geneva, 1995.
FDA, Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics. Food and Drug Administration, Rockville, MD, 1987.
Dong W M. Modern HPLC for Practicing Scientists; A Wiley- Interscience publication, USA, 2006, pp 1-9. https://doi.org/10.1002/0471973106
Kazakevich Y and LoBrutto R. HPLC for pharmaceutical Scientists;A John Wiley and sons, 2007, pp 1-6. https://doi.org/10.1002/9780470087954.ch1
Snyder LR, Kirkland JJ and Glajch LJ. Introduction to Modern Liquid Chromatography; 2nd Edn; A Wiley- Inter science publication, NY, USA, 1997, pp 5-42.
Skoog D.A, West D.M and Holler D.F; Fundamentals of Analytical Chemistry; 8th Edn, Saunders College Publishing, 2004, pp 973-992.
Sharma B.K, Instrumental Methods of Chemical Analysis; 25th Edn; GOEL Publication House, Meerut, pp 286-385.
Michael E S., and Ira S K. Analytical Method Development and Validation; Marcel Dekker, Inc., New York, 1997, pp 25-29.
John Lacey, Patrick Flanigan, "Genzyme Seeks U.S Approval for Clolar to treat adult AML" Cambridge, 2008.
Clofarabine "Drug profile" , Oct 2015, https://us.chemicalbook.com/ChemicalProductProperty_US_CB2277491.aspx
Clofarabine "Drug profile" , Oct 2015, https://www.chemicalland21.com/specialtychem/nd/CLOFARABINE.htm
Clofarabine "Drug profile" , Oct 2015, https://www.drugs.com/cdi/clofarabine.html
Clofarabine "Drug profile" , Oct 2015, https://www.scbt.com/datasheet-278864-clofarabine.html
Pokharana M, Vaishnav R, Goyal A, Shrivastava A, Stability testing guidelines of pharmaceutical products, Journal of Drug Delivery and Therapeutics 2018; 8(2):169-175
Wang Juan, Zhang Rong, ZHAO Yan-yan, Lu Lai-chun, "High- performance liquid chromatography Clofarabine Injection Content." Med Pap Pharm Pap 2009
Hsieh Y, Duncan CJ, Lee S, Liu M. Comparison of fast liquid chromatography/tandem mass spectrometric methods for simultaneous determination of cladribine and clofarabine in mouse plasma. J Pharm Biomed Anal. 2007 Jun 28; 44(2):492-7. Epub 2007 Feb 13. https://doi.org/10.1016/j.jpba.2007.02.007
Tu X, Lu Y,,Zhong D, Zhang Y, Chen X, "A sensitive LC-MS/MS method for quantifying Clofarabine triphosphate concentrations in human peripheral blood mononuclear cells." J Chromatogr B Analyt Technol Biomed Life Sci. 2014; 202-207 https://doi.org/10.1016/j.jchromb.2014.01.021
Venkata N, Jalandhar D, Gnana G, Rajendar B, Manoj P, Dhananiay D, Venkata N "Development of supercritical fluid (carbon dioxide) based ultra performance convergence chromatographic stability indicating assay method for the determination of clofarabine in injection" Mylan Laboratories Ltd, 2013; 7008-7013 https://doi.org/10.1039/c3ay41561a
Published
How to Cite
Issue
Section
Copyright (c) 2022 Deepak Kumar Sehrawat, Neetesh Kumar Jain, Apoorva Tiwari, Prerna Chaturvedi
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
.