Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode
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2007
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
The multi-component preparation Co -Diovan (R) is indicated for the hypertension treatment in patients whose blood pressure is not adequately controlled by monotherapy. Its active ingredients are valsartan and hydrochlorothiazide. The reversed-phase high performance liquid chromatographic method (RP -HPLC) for the determination of valsartan and hydrochlorothiazide, as well as their impurities level, was developed and described in this paper. As the investigated substances were structurally different with extremely different lipophilicity and polarity, isocratic elution was not possible, so an optimal gradient mode was settled on. The chromatograms were recorded using the Agilent 1100 Series chromatographic system with DAD detector. Separations were performed on a Hypersil 120-5 ODS column (250 mm x 4.6 mm; 5 mm particle size) at 25 degrees C column temperature. The gradient high performance liquid chromatographic system was developed, and the following mobile phases were used: A) mixtu...re acetonitrile -water (10: 90 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid, and B) mixture acetonitrile -water (90: 10 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid. Injection volume was 50 mu L, flow rate 1 mL min(-1) and UV detection was performed at 256 nm. Methyl parahydroxybenzoate was used as an internal standard and acetonitrile-water (40:60 V/V) as a solvent. Afterwards, the developed method was subjected to the method validation. The investigated validation parameters (selectivity, linearity, precision, accuracy, LOQ, and LOD) proved the suitability of the method for the simultaneous determination of valsartan, hydrochlorothiazide, and their impurities in appropriate tablets.
Ključne reči:
high performance liquid chromatography / validation / valsartan / hydrochlorothiazide / impuritiesIzvor:
Journal of Liquid Chromatography & Related Technologies, 2007, 30, 19, 2879-2890Izdavač:
- Taylor & Francis Inc, Philadelphia
Finansiranje / projekti:
- Formulisanje i Karakterizacija separacionih sistema za modelovanje retencionog ponašanja lekovitih supstancija uz hemometrijsku evaluaciju (RS-MESTD-MPN2006-2010-142077)
DOI: 10.1080/10826070701588638
ISSN: 1082-6076
WoS: 000250551600006
Scopus: 2-s2.0-34548306907
Institucija/grupa
PharmacyTY - JOUR AU - Ivanović, Darko AU - Malenović, Anđelija AU - Jančić, Biljana AU - Medenica, Mirjana AU - Masković, Marija PY - 2007 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/941 AB - The multi-component preparation Co -Diovan (R) is indicated for the hypertension treatment in patients whose blood pressure is not adequately controlled by monotherapy. Its active ingredients are valsartan and hydrochlorothiazide. The reversed-phase high performance liquid chromatographic method (RP -HPLC) for the determination of valsartan and hydrochlorothiazide, as well as their impurities level, was developed and described in this paper. As the investigated substances were structurally different with extremely different lipophilicity and polarity, isocratic elution was not possible, so an optimal gradient mode was settled on. The chromatograms were recorded using the Agilent 1100 Series chromatographic system with DAD detector. Separations were performed on a Hypersil 120-5 ODS column (250 mm x 4.6 mm; 5 mm particle size) at 25 degrees C column temperature. The gradient high performance liquid chromatographic system was developed, and the following mobile phases were used: A) mixture acetonitrile -water (10: 90 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid, and B) mixture acetonitrile -water (90: 10 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid. Injection volume was 50 mu L, flow rate 1 mL min(-1) and UV detection was performed at 256 nm. Methyl parahydroxybenzoate was used as an internal standard and acetonitrile-water (40:60 V/V) as a solvent. Afterwards, the developed method was subjected to the method validation. The investigated validation parameters (selectivity, linearity, precision, accuracy, LOQ, and LOD) proved the suitability of the method for the simultaneous determination of valsartan, hydrochlorothiazide, and their impurities in appropriate tablets. PB - Taylor & Francis Inc, Philadelphia T2 - Journal of Liquid Chromatography & Related Technologies T1 - Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode VL - 30 IS - 19 SP - 2879 EP - 2890 DO - 10.1080/10826070701588638 ER -
@article{ author = "Ivanović, Darko and Malenović, Anđelija and Jančić, Biljana and Medenica, Mirjana and Masković, Marija", year = "2007", abstract = "The multi-component preparation Co -Diovan (R) is indicated for the hypertension treatment in patients whose blood pressure is not adequately controlled by monotherapy. Its active ingredients are valsartan and hydrochlorothiazide. The reversed-phase high performance liquid chromatographic method (RP -HPLC) for the determination of valsartan and hydrochlorothiazide, as well as their impurities level, was developed and described in this paper. As the investigated substances were structurally different with extremely different lipophilicity and polarity, isocratic elution was not possible, so an optimal gradient mode was settled on. The chromatograms were recorded using the Agilent 1100 Series chromatographic system with DAD detector. Separations were performed on a Hypersil 120-5 ODS column (250 mm x 4.6 mm; 5 mm particle size) at 25 degrees C column temperature. The gradient high performance liquid chromatographic system was developed, and the following mobile phases were used: A) mixture acetonitrile -water (10: 90 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid, and B) mixture acetonitrile -water (90: 10 V/V); pH of the mobile phase was adjusted to 2.5 with 85% orthophosphoric acid. Injection volume was 50 mu L, flow rate 1 mL min(-1) and UV detection was performed at 256 nm. Methyl parahydroxybenzoate was used as an internal standard and acetonitrile-water (40:60 V/V) as a solvent. Afterwards, the developed method was subjected to the method validation. The investigated validation parameters (selectivity, linearity, precision, accuracy, LOQ, and LOD) proved the suitability of the method for the simultaneous determination of valsartan, hydrochlorothiazide, and their impurities in appropriate tablets.", publisher = "Taylor & Francis Inc, Philadelphia", journal = "Journal of Liquid Chromatography & Related Technologies", title = "Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode", volume = "30", number = "19", pages = "2879-2890", doi = "10.1080/10826070701588638" }
Ivanović, D., Malenović, A., Jančić, B., Medenica, M.,& Masković, M.. (2007). Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode. in Journal of Liquid Chromatography & Related Technologies Taylor & Francis Inc, Philadelphia., 30(19), 2879-2890. https://doi.org/10.1080/10826070701588638
Ivanović D, Malenović A, Jančić B, Medenica M, Masković M. Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode. in Journal of Liquid Chromatography & Related Technologies. 2007;30(19):2879-2890. doi:10.1080/10826070701588638 .
Ivanović, Darko, Malenović, Anđelija, Jančić, Biljana, Medenica, Mirjana, Masković, Marija, "Monitoring of impurity level of valsartan and hydrochlorothiazide employing an RP-HPLC gradient mode" in Journal of Liquid Chromatography & Related Technologies, 30, no. 19 (2007):2879-2890, https://doi.org/10.1080/10826070701588638 . .