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

Zhang, Xi; Jia, Xinbei; Tong, Wei; Chen, Hui; Lei, Ning; Li, Guangrun; Tai, Jun; Li, Pengfei

doi:10.1039/d2ra05843j

RSC Adv.

2022

DOI: 10.1039/d2ra05843j

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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

Xi Zhang

Xinbei Jia

Wei Tong³

et al.

Abstract: Clofarabine is approved for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients aged 1 to 21 years.

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A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms

Aluri

Annapurna

2023

RJPT

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Clofarabine is an anti-cancer drug. A new stability indicating isocratic RP-HPLC and LC-APCI-MS methods have been developed and validated for the quantification of Clofarabine as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A mixture of 0.1% Formic acid: Acetonitrile was used as mobile phase on gradient mode and a mixture of Methanol: Water (50:50, v/v) was used as diluent. A wide linearity concentration range 5.0-150 μg/mL was shown by the proposed method. The proposed methods are simple, precise, and accurate are used to quantify the marketed formulations of Clofarabine. Stress degradation studies were performed and the method is found to be selective and specific.

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A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms

Aluri

Annapurna

2023

RJPT

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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

Abstract: Clofarabine is approved for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients aged 1 to 21 years.

Cited by 1 publication

References 29 publications

A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms

A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Clofarabine in pharmaceutical dosage forms

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