Current Issues of Pharmacy and Medical Sciences

Curr Issues Pharm Med Sci., Vol. 36, No. 2, 81-86

Rakesh U. Shelke*, Dinesh D. Rishipathak

  Department of Pharmaceutical Chemistry, Bhujbal Knowledge City, MET’s Institute of Pharmacy, Affilated to Savitribai Phule Pune University, Adgaon, Nashik, Maharashtra, India

  10.2478/cipms-2023-0014

​© 2023 Author(s). This is an open access article distributed under the Creative Commons Attribution-NonComercial-No Derivs licence (http://creativecommons.org/licenses/by-nc-nd/3.0/)

Abstract

A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of Ribociclib in Spiked Human Plasma by HPLC-UV was developed and validated. Ribociclib (RCB) and the internal standard (IS), Trifluridine, were first extracted from plasma samples by a simple Protein Precipitation extraction using Acetonitrile. Plasma concentration of RCB and internal standard were then analyzed by applying reversed phase chromatography using Orochem orosil C18 (4.6 mm × 250 mm, 5 μ) and elution with a isocratic mobile phase consisting of 10 mM phosphate buffer – Acetonitrile (60:40, v/v) adjusted to pH 3.0 at a flow rate of 1.0 ml/min. Detection of RCB and the IS was subsequently done at a wave-length of 260 nm. The limit of quantification was 10 ng/ml. The calibration curve was linear (R2>0.998) over the concentration range of 10-1000 ng/ml. For human plasma, the accuracy and precision were within ±15% and ≤15%, respectively, for all concentrations, except for the lower limit of quantification, where they were within ≤20%.

Full Text

Keywords

bioanalytical methods, protein precipitation, validation, Spiked Human Plasma.