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Development and Validation of Novel RP-HPLC Method for Determination of Assay and Related Substances of Flucytosine in Drug Product
Corresponding Author(s) : T. Somanathan
Asian Journal of Chemistry,
Vol. 34 No. 10 (2022): Vol 34 Issue 10, 2022
Abstract
A novel, rapid, simple and cost-effective RP-HPLC method was developed for the assay of flucytosine and its related substances in drug product (tablets). The developed method was subjected to validation challenges as per the ICH guidelines and the method found to follow all the validation challenges successfully. Method employed uses a column with L1 end-capped stationary phase having dimensions of 250 mm × 4.6 mm, 5 μm. The mobile phase comprised of 10 mM phosphate buffer and methanol in gradient mode. The detection was performed at 210 nm. The flucytosine peak eluted at about 5.5 min making the method cost-effective. In this method, the related substances were also quantified. Owing to short run time, simple chromatographic conditions and sample preparation, the method is claimed to be ideal for the routine high throughput analysis leading to low cost of testing.
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- G. Song, G. Liang and W. Liu, Mycopathologia, 185, 599 (2020); https://doi.org/10.1007/s11046-020-00462-9
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References
G. Song, G. Liang and W. Liu, Mycopathologia, 185, 599 (2020); https://doi.org/10.1007/s11046-020-00462-9
A.H. Limper, A. Adenis, T. Le and T.S. Harriso, Lancet Infect. Dis., 17, e334 (2017); https://doi.org/10.1016/S1473-3099(17)30303-1
V. Cavrini, D. Bonazzi and A.M. Di Pietra, J. Pharm. Biomed. Anal., 9, 401 (1991); https://doi.org/10.1016/0731-7085(91)80164-5
I. Shoukrallah, A. Sakla and R. Wintersteiger, Anal. Lett., 23, 843 (1990); https://doi.org/10.1080/00032719008052486
P.V. Naveen and S. Ganapaty, Res. J. Pharm. Tech., 14, 289 (2021); https://doi.org/10.5958/0974-360X.2021.00052.4
A. Vermes, J. Antimicrob. Chemother., 46, 171 (2000); https://doi.org/10.1093/jac/46.2.171
N.M. Bhatt, V.D. Chavada, D.P. Patel, P. Sharma, M. Sanyal and P.S. Shrivastav, Int. J. Adv. Pharm. Anal., 5, 1 (2015); https://doi.org/10.1016/j.jpha.2014.08.001
M. Ubale, M. Shioorkar and V. Choudhari, Int. J. Innov. Eng. Tech., 8, 155 (2017).
A. Murugesan and A.M. Mathrusri, Acta Sci. Pharm. Sci., 6, 59 (2022); https://doi.org/10.31080/ASPS.2021.05.0818
J.-W. Alffenaar, K. van Hateren and D.J. Touw, J. Appl. Bioanal., 4, 157 (2018); https://doi.org/10.17145/jab.18.020
R.W. Bury, M.L. Mashford and H.M. Miles, Antimicrob. Agents Chemother., 16, 529 (1979); https://doi.org/10.1128/AAC.16.5.529
T.K.C. Ng, R.C.Y. Chan, F.A.B. Adeyemi-Doro, S.W. Cheung and A.F.B. Cheng, J. Antimicrob. Chemother., 37, 465 (1996); https://doi.org/10.1093/jac/37.3.465
D.J. Schiavone, M.D. Page and J.K. Dawborn, BMJ, 4, 380 (1973); https://doi.org/10.1136/bmj.4.5889.380
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonized Tripartite Guideline (2005).