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ABSTRACT
A highly accurate and precise HPLC-UV method was developed for identification and quantification of gemcitabine anti-cancer drug in rat plasma. A new magnetic graphene oxide-based calixarene composite was developed and used as a solid phase for extraction of gemcitabine from rat plasma. Extraction efficiency has been studied by varying different experimental variables (eluent type, sorbent amount, extraction time and eluent volume etc.) and these were evaluated and optimized. Magnetic solid phase extraction (MSPE) conditions such as amount of solid phase, extraction solvents and their amounts, and adsorption and desorption times were optimized for getting better recoveries. Under the optimized conditions, linearity was evaluated with good correlation coefficient value R2 (0.9993). Limit of detection (2.0 ng/mL) and limit of quantification (13.0 ng/mL) was assessed using signal-to-noise ratio method. Intraday precision RSD values of gemcitabine (GEM) were found to be less than 4.6% and interday precision values are less than 6.8%. The results obtained during the robustness study were RSD values between 1.2 and 4.6%; these results indicate that the method has effective performance and reliability. The recovery percentages of gemcitabine at three QC level concentrations were obtained in the range from 97.6 to 100.2%.
Acknowledgments
The authors would like to for National Institute of Technology-Warangal for providing infrastructural facilities to carry out this research work. The authors also thank Prof C.P Rao, IIT-Tirupati, Andhra Pradesh for providing calix[4/6]arene.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Author contributions
Babji P: Framed the methodology of the work, and Investigated, Validated by performing the formal analysis. Babji P and Jugun Prakash C: Conceptualization of the work and Drafted the original paper. Amarbabu N: Assisted in the formal analysis. Jugun Prakash C: Visualized and supervised the overall experimental work.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/01496395.2023.2201392.
Statement of novelty
Gemcitabine (GEM) is one of the USFDA approved drug for the pancreatic cancer. In view of pharmaceutical importance of GEM, numerous analytical techniques have been developed for the determination and quantifications of GEM in biological fluids and individually. The reported methods are based on high performance liquid chromatography (HPLC), gas chromatography (GC), liquid chromatography with mass spectrometry (LC-MS), fluorescence sensing and electrochemical determination. In general, LC-MS/MS method show high sensitivity and selectivity in the analysis of drug molecules in comparison with HPLC method. But the problem with LC-MS/MS method is expensive equipment and solvents, therefore maintenance is burden to the working groups. Hence, the main aim of this study is to develop a simple, precise, accurate, fast and sensitive analytical method for the determination and quantification of GEM from plasma. Here, we have developed a new calixarene based MGO-C[6]A composite and applied as magnetic solid phase(MSP) for the extraction of GEM from the plasma, followed by the reverse phase high performance liquid chromatography (RP-HPLC). Under the optimized conditions, linearity was evaluated with good correlation coefficient value R2 (0.9993). Limit of detection (2.0 ng/mL) and Limit of quantification (13.0 ng/mL) was assessed by using signal to noise ratio method. As far as we know, the extraction of GEM from plasma using MGO-C[6]A have not been reported till now. Overall, a highly accurate, precise and sensitive HPLC-UV method was developed for identification and quantification of Gemcitabine anti-cancer drug in rat plasma and applied to pharmacokinetic analysis. The current studies will definitely of interest to the community of biomedical and pharmaceutical sciences.