Determination of carvedilol and its impurities in pharmaceuticals
Abstract
A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials.
Keywords:
column liquid chromatography / carvedilol / impurities and degradation products / pharmaceutical preparationsSource:
Chromatographia, 2005, 62, 9-10, 539-542Publisher:
- Vieweg, Wiesbaden
DOI: 10.1365/s10337-005-0656-y
ISSN: 0009-5893
WoS: 000233470100014
Scopus: 2-s2.0-27944471303
Collections
Institution/Community
PharmacyTY - JOUR AU - Stojanović, J AU - Marinković, Valentina AU - Vladimirov, S AU - Veličković, D. AU - Sibinović, Predrag PY - 2005 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/623 AB - A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials. PB - Vieweg, Wiesbaden T2 - Chromatographia T1 - Determination of carvedilol and its impurities in pharmaceuticals VL - 62 IS - 9-10 SP - 539 EP - 542 DO - 10.1365/s10337-005-0656-y ER -
@article{ author = "Stojanović, J and Marinković, Valentina and Vladimirov, S and Veličković, D. and Sibinović, Predrag", year = "2005", abstract = "A reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for separation of carvedilol and its impurities from Karvileks tablets. The best separation was achieved on a 100 mm x 4.6 mm, 5 mu m particle size, Chromolit RP 8e column. Use of acetonitrile-water, 45:55 (v/v), adjusted to pH 2.5 with formic acid, as mobile phase at a flow rate of 0.5 mL min(-1) enabled acceptable resolution of carvedilol, in large excess, from possible impurities, in a short elution time. UV detection was performed at 280 nm. Linearity, accuracy, precision, selectivity, and robustness were validated and found to be satisfactory. Overall, the proposed method was found to be highly sensitive, suitable, and accurate for quantitative determination of carvedilol and its impurities in dosage forms and in raw materials.", publisher = "Vieweg, Wiesbaden", journal = "Chromatographia", title = "Determination of carvedilol and its impurities in pharmaceuticals", volume = "62", number = "9-10", pages = "539-542", doi = "10.1365/s10337-005-0656-y" }
Stojanović, J., Marinković, V., Vladimirov, S., Veličković, D.,& Sibinović, P.. (2005). Determination of carvedilol and its impurities in pharmaceuticals. in Chromatographia Vieweg, Wiesbaden., 62(9-10), 539-542. https://doi.org/10.1365/s10337-005-0656-y
Stojanović J, Marinković V, Vladimirov S, Veličković D, Sibinović P. Determination of carvedilol and its impurities in pharmaceuticals. in Chromatographia. 2005;62(9-10):539-542. doi:10.1365/s10337-005-0656-y .
Stojanović, J, Marinković, Valentina, Vladimirov, S, Veličković, D., Sibinović, Predrag, "Determination of carvedilol and its impurities in pharmaceuticals" in Chromatographia, 62, no. 9-10 (2005):539-542, https://doi.org/10.1365/s10337-005-0656-y . .