ABSTRACT

Objective: This study points to build up and validate a simple methodology to quantify the most used drug Carfilzomib for the treatment of cancer, in human plasma for preclinical studies and validate as per ICH guidelines. Methods: Carfilzomib was isolated from plasma samples by liquid-liquid extraction method. Chromatographic separation was achieved on Agilent Column (100 mm ×4.6 mm, 2.5 ?m). The mobile phase consisted of 0.05 % orthophosphoric acid (OPA) buffer pH 3 and methanol in the ratio of (32:68, v/v), respectively at a flow rate 0.7 ml/min. The Diode array detector (DAD) detection was carried out at 256 nm. The suggested method was validated by performing linearity, system suitability, sensitivity, accuracy, precision, LOD, LOQ, and robustness. The method was validated as per ICH guidelines. Results: The retention time of Carfilzomib was found to be 3.525 min .the calibration curves are linear (r2 = 0.999) over the concentration range of 5-25?g/ml of plasma analytes concentration. Percentage means recovery of Carfilzomib from spiked plasma was98.6%. All the validated parameters were found to be within the limit. Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for quantitative estimation of Carfilzomib inhuman plasma and should be suitable for conducting pharmacokinetics studies and therapeutic drug monitoring. Keywords: Carfilzomib, Human plasma, RP-HPLC, Validation, DAD Detector
Publication date: 25/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_JAN_SPCL_2_2026.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.2026