Author(s): Ankit Kumar, Sachin Kumar Singh, Monica Gulati, Bimlesh Kumar, Rahul Prasher, Jayprakash Gupta, Diksha Mankotia, Narendra Kumar Pandey, Saurabh Singh

Email(s): singhsachin23@gmail.com

DOI: 10.5958/0974-360X.2021.00032.9   

Address: Ankit Kumar, Sachin Kumar Singh*, Monica Gulati, Bimlesh Kumar, Rahul Prasher, Jayprakash Gupta, Diksha Mankotia, Narendra Kumar Pandey, Saurabh Singh
School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 2021


ABSTRACT:
An analytical method was developed to quantify 5-Fluorouracil (5-FU) using reverse phase high performance liquid chromatograph (RP-HPLC). A C-18 reverse-phase column was used as stationary phase for the separation of 5-FU. Potassium dihydrogen orthophosphate buffer (0.05 M) containing 0.1% of Triethanolamine (TEA) was use as a mobile phase to facilitate the elution. The flow rate was 1.2mL min-1 and the chromatogram of 5-FU was detected at wavelength of 266nm. 5-Bromouracil (5-BU) was used as internal standard. Method was validated as per ICH Q2 (R1) guidelines. The retention time of 5-FU was found to be 7.568 min and 5-BU was 20.067 min. The developed method was found to be linear at a concentration range of 2-10µg/mL with r2 of 0.9996. The mean percentage recovery of 5-FU was found within 95-105 % at all the levels which indicated that the method was accurate. The percentage relative standard deviation was found less than 2% which indicated that method was satisfactorily précised. The LOD and LOQ for 5-FU were found to be 3.3 and 0.83 respectively. The method was found to be robust as there was no significant change in response with variation in the flow rate and wavelength. It was concluded that the developed method has passed all the validation tests and can be successfully applied to estimate the presence of 5-FU in bulk as well as in pharmaceutical formulations.


Cite this article:
Ankit Kumar, Sachin Kumar Singh, Monica Gulati, Bimlesh Kumar, Rahul Prasher, Jayprakash Gupta, Diksha Mankotia, Narendra Kumar Pandey, Saurabh Singh. Method development and Validation for the Estimation of 5-Fluorouracil by using Reverse phase high-performance liquid chromatography. Research J. Pharm. and Tech. 2021; 14(1):185-188. doi: 10.5958/0974-360X.2021.00032.9

Cite(Electronic):
Ankit Kumar, Sachin Kumar Singh, Monica Gulati, Bimlesh Kumar, Rahul Prasher, Jayprakash Gupta, Diksha Mankotia, Narendra Kumar Pandey, Saurabh Singh. Method development and Validation for the Estimation of 5-Fluorouracil by using Reverse phase high-performance liquid chromatography. Research J. Pharm. and Tech. 2021; 14(1):185-188. doi: 10.5958/0974-360X.2021.00032.9   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-1-32


REFERENCES:
1.    Straub JO. Combined Environmental Risk Assessment for 5-Fluorouracil and Capecitabine in Europe Integrated Environmental Assessment and Management. 2010; 6: 540-66.
2.    Hagmann W, Jesnowski R, Faissner R, Guo C, Lohr JM. ATP-binding cassette C transporters in human pancreatic carcinoma cell lines. Upregulation in 5 fluorouracil resistant cells. Pancreatology. 2009; 9: 136-44.
3.    Summary of Product Characteristics (SmPC). 5-Fluorouracil 50mg/ml injection. Hospira UK. Ltd. Available from: https://www.medicines.org.uk/emc/product/3791/smpc
4.    5-Fluorouracil (5-FU). MACMILLAN Cancer Support (reviewed on 31 May 2018). Available from: https://www.macmillan.org.uk/information-and-support/treating/chemotherapy/drugs-and-combination-regimens/individual-drugs/fluorouracil.html
5.    ICH Validation of Analytical Procedure. Text and Methodology Q2 (R1). Geneva: International Conference on Harmonization, 2005.

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