An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the analysis of a novel antimigraine drug, rizatriptan benzoate, in a dosage form along with its two impurities, L-749.019 and L-783.540. The method used a C-18 XTerra (TM) ( 150 x 3.9 mm), 5 mm column. The mobile phase consisted of a mixture of methanol, TEA (1%) and 10 mM KH2PO4 ( 5: 9.5: 85.5 v/v) at a flow rate of 1.2 ml min(-1) ( pH of the water phase was adjusted to 5.5 with 85% orthophosphoric acid). Column temperature was 20 degrees C and the detection was performed at 225 nm. The central composite design technique and the response surface method were used in the robustness test considerations. The method was applied satisfactorily to the analysis of commercial rizatriptan formulation.
Keywords:
rizatriptan benzoate / impurities / dosage form / RP HPLC / method validation
TY - JOUR
AU - Jocić, B.
AU - Zečević, Mira
AU - Živanović, Lj.
AU - Licanski, A.
PY - 2007
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/982
AB - An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the analysis of a novel antimigraine drug, rizatriptan benzoate, in a dosage form along with its two impurities, L-749.019 and L-783.540. The method used a C-18 XTerra (TM) ( 150 x 3.9 mm), 5 mm column. The mobile phase consisted of a mixture of methanol, TEA (1%) and 10 mM KH2PO4 ( 5: 9.5: 85.5 v/v) at a flow rate of 1.2 ml min(-1) ( pH of the water phase was adjusted to 5.5 with 85% orthophosphoric acid). Column temperature was 20 degrees C and the detection was performed at 225 nm. The central composite design technique and the response surface method were used in the robustness test considerations. The method was applied satisfactorily to the analysis of commercial rizatriptan formulation.
PB - Taylor & Francis Inc, Philadelphia
T2 - Analytical Letters
T1 - A chemometrical approach to optimization and validation of an HPLC assay for rizatriptan and its impurities in tablets
VL - 40
IS - 12
SP - 2301
EP - 2316
DO - 10.1080/00032710701575959
ER -
@article{
author = "Jocić, B. and Zečević, Mira and Živanović, Lj. and Licanski, A.",
year = "2007",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/982",
abstract = "An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the analysis of a novel antimigraine drug, rizatriptan benzoate, in a dosage form along with its two impurities, L-749.019 and L-783.540. The method used a C-18 XTerra (TM) ( 150 x 3.9 mm), 5 mm column. The mobile phase consisted of a mixture of methanol, TEA (1%) and 10 mM KH2PO4 ( 5: 9.5: 85.5 v/v) at a flow rate of 1.2 ml min(-1) ( pH of the water phase was adjusted to 5.5 with 85% orthophosphoric acid). Column temperature was 20 degrees C and the detection was performed at 225 nm. The central composite design technique and the response surface method were used in the robustness test considerations. The method was applied satisfactorily to the analysis of commercial rizatriptan formulation.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Analytical Letters",
title = "A chemometrical approach to optimization and validation of an HPLC assay for rizatriptan and its impurities in tablets",
volume = "40",
number = "12",
pages = "2301-2316",
doi = "10.1080/00032710701575959"
}
Jocić, B., Zečević, M., Živanović, Lj.,& Licanski, A. (2007). A chemometrical approach to optimization and validation of an HPLC assay for rizatriptan and its impurities in tablets.
Analytical Letters
Taylor & Francis Inc, Philadelphia., 40(12), 2301-2316.
https://doi.org/10.1080/00032710701575959
Jocić B, Zečević M, Živanović L, Licanski A. A chemometrical approach to optimization and validation of an HPLC assay for rizatriptan and its impurities in tablets. Analytical Letters. 2007;40(12):2301-2316
Jocić B., Zečević Mira, Živanović Lj., Licanski A., "A chemometrical approach to optimization and validation of an HPLC assay for rizatriptan and its impurities in tablets" Analytical Letters, 40, no. 12 (2007):2301-2316,
https://doi.org/10.1080/00032710701575959 .
