Analytical Techniques for the Assay of Clofarabine: A Review

Mukthinuthalapati Mathrusri Annapurna* and Anga Swapana

GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India.

Received: September 24, 2024; Published: September 28, 2024

Citation: Mukthinuthalapati Mathrusri Annapurna and Anga Swapana . “Analytical Techniques for the Assay of Clofarabine: A Review". Acta Scientific Pharmaceutical Sciences 8.10 (2024):26-27.

Abstract

Clofarabine is an antineoplastic drug which acts by inhibiting the DNA synthesis and ribonucleotide reductase. In the present study the authors have summarised the analytical methods so far published for the estimation of Clofarabine in the literature.

Keywords: Clofarabine; Food and Drug Administration (FDA)

Introduction

Clofarabine is an anti-cancer drug [1,2]. In 2004, the Food and Drug Administration (FDA) has approved. Chemically it is 5-(6-amino-2-chloro-purin-9-yl) -4-fluoro-2- (hydroxymethyl) oxolan-3-ol with molecular formula C₁₀H₁₁ClFN₅O₃ and molecular weight 303.68 grams/mole. Clofarabine (CAS no. 123318-82-1) converts in to its active triphosphate form and thereby competes with adenine triphosphate for use by DNA polymerase and finally leads to DNA damage that can trigger apoptotic pathways. Clofarabine (Figure 1) is used to treat leukemia in patients 1 to 21 years old.

Literature survey reveals that Clofarabine was studied by different analytical methods such as LC-MS/MS [3-5] HPTLC [6], HPLC [7-11] and UPLC [12] were developed for the estimation of Clofarabine and its impurities in pharmaceutical formulations and biological fluids. The earlier reported methods were summarized in Table 1.

Conclusion

This review article explains different analytical methods as well as techniques developed for the estimation of Clofarabine in pharmaceutical formulations as well as body fluids.

Bibliography

1. Pession A., et al. “Use of Clofarabine for acute childhood leukemia”. Biologics 4 (2010): 111-118.
2. Harned TM and Gaynon PS. “Treating refractory leukemias in childhood, role of Clofarabine”. Therapeutics and Clinical Risk Management 2 (2008): 327-336.
3. Kiran Kumar V., et al. “Sensitive and rapid high performance liquid chromatography tandem mass spectrometry method (LC/MS/MS) for the estimation of Clofarabine in rabbit plasma”. World Journal of Pharmaceutical Research2 (2019): 1422-1432.
4. Sai Gnaneswari Aluri and Mukthinuthalapati Mathrusri Annapurna. “A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms”. Research Journal of Pharmacy and Technology 5 (2023): 2485-2491.
5. Zhang X., et al. “Quantification of Clofarabine in urine and plasma by LC-MS/MS: suitable for PK study and TDM in pediatric patients with relapsed or refractory ALL”. RSC Advances51 (2022): 33091-33098.
6. Brijesh Patel., et al. “Estimation of newer anti-cancer drug Clofarabine in their pharmaceutical dosage form by stability indicating TLC method”. Journal of the Chilean Chemical Society1 (2018): 3834-3840.
7. Deepak Kumar Sehrawat., et al. “Stability indicating RP-HPLC method for the estimation of Clofarabine in parenteral formulation”. International Journal of Medical Sciences and Pharma Research2 (2022): 72-82.
8. Shirman Asif., et al. “Development and validation of analytical method for quantitation of Clofarabine”. Indian Drugs 59 (2022): 60-63.
9. Chaithanya Sudha PD. “Validated RP-HPLC method for the determination of Clofarabine in bulk and tablet dosage”. Journal of Pharmaceutical Sciences and Research5 (2019): 1781-1786.
10. Jagadeswara Rao K., et al. “Validated reverse phase stability-indicating HPLC method for Clofarabine in the presence of degradation products and its process-related impurities”. IOSR Journal of Pharmacy and Biological Sciences6 (2016): 63-72.
11. Jinal N Tandel., et al. “Quantification of Clofarabine and its impurity substances by RP-HPLC method in parenteral formulation”. International Journal of Pharmaceutical Sciences and Nanotechnology4 (2018): 3794-3803.
12. Dhananjay Prasad D., et al. “Ultra-performance liquid chromatographic method for quantification of Clofarabine related substances in an injection formulation”. International Journal of Innovative Science and Research Technology7 (2017): 334-345.

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Copyright: © 2024 Mukthinuthalapati Mathrusri Annapurna and Anga Swapana. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.