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High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals

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Authors
Letica, Jelena
Marković, Slavko
Zirojević, Jelena
Nikolić, Katarina
Agbaba, Danica
Article (Published version)
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Abstract
An RP-HPLC method for simultaneous separation and quantification of pantoprazole and its five main impurities in pharmaceutical formulations was developed and validated. The separation was accomplished on a Zorbax Eclipse XDB C18 column (5 mu m particle size, 150 x 4.6 mm id) using a gradient with mobile phase A [buffer-acetonitrile (70 + 30, v/v)], and mobile phase B [buffer-acetonitrile (30 + 70, v/v)]. The buffer was 0.01 M ammonium acetate solution with addition of 1 mL triethylamine/L of the solution, adjusted to pH 4.5 with orthophosphoric acid. The eluent flow rate was 1 mL/min, the temperature of the column was 30 C, and the eluate was monitored at 290 nm. Linearity (r = 0.999), recovery (97.6-105.8%), RSD (0.55-1.90%), and LOQ (0.099-1.48 mu g/mL) were evaluated and found to be satisfactory. The proposed method can be used for simultaneous identification and quantification of the analyzed compounds in pharmaceutical formulations.
Source:
Journal of AOAC International, 2010, 93, 4, 1121-1128
Publisher:
  • AOAC Int, Gaithersburg
Funding / projects:
  • Sinteza, kvantitativni odnosi između strukture/osobina i aktivnosti, fizičko-hemijska karakterizacija i analiza farmakološki aktivnih supstanci (RS-142071)

ISSN: 1060-3271

PubMed: 20922942

WoS: 000281492100009

Scopus: 2-s2.0-77956162993
[ Google Scholar ]
9
7
Handle
https://hdl.handle.net/21.15107/rcub_farfar_1334
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1334
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Letica, Jelena
AU  - Marković, Slavko
AU  - Zirojević, Jelena
AU  - Nikolić, Katarina
AU  - Agbaba, Danica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1334
AB  - An RP-HPLC method for simultaneous separation and quantification of pantoprazole and its five main impurities in pharmaceutical formulations was developed and validated. The separation was accomplished on a Zorbax Eclipse XDB C18 column (5 mu m particle size, 150 x 4.6 mm id) using a gradient with mobile phase A [buffer-acetonitrile (70 + 30, v/v)], and mobile phase B [buffer-acetonitrile (30 + 70, v/v)]. The buffer was 0.01 M ammonium acetate solution with addition of 1 mL triethylamine/L of the solution, adjusted to pH 4.5 with orthophosphoric acid. The eluent flow rate was 1 mL/min, the temperature of the column was 30 C, and the eluate was monitored at 290 nm. Linearity (r = 0.999), recovery (97.6-105.8%), RSD (0.55-1.90%), and LOQ (0.099-1.48 mu g/mL) were evaluated and found to be satisfactory. The proposed method can be used for simultaneous identification and quantification of the analyzed compounds in pharmaceutical formulations.
PB  - AOAC Int, Gaithersburg
T2  - Journal of AOAC International
T1  - High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals
VL  - 93
IS  - 4
SP  - 1121
EP  - 1128
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1334
ER  - 
@article{
author = "Letica, Jelena and Marković, Slavko and Zirojević, Jelena and Nikolić, Katarina and Agbaba, Danica",
year = "2010",
abstract = "An RP-HPLC method for simultaneous separation and quantification of pantoprazole and its five main impurities in pharmaceutical formulations was developed and validated. The separation was accomplished on a Zorbax Eclipse XDB C18 column (5 mu m particle size, 150 x 4.6 mm id) using a gradient with mobile phase A [buffer-acetonitrile (70 + 30, v/v)], and mobile phase B [buffer-acetonitrile (30 + 70, v/v)]. The buffer was 0.01 M ammonium acetate solution with addition of 1 mL triethylamine/L of the solution, adjusted to pH 4.5 with orthophosphoric acid. The eluent flow rate was 1 mL/min, the temperature of the column was 30 C, and the eluate was monitored at 290 nm. Linearity (r = 0.999), recovery (97.6-105.8%), RSD (0.55-1.90%), and LOQ (0.099-1.48 mu g/mL) were evaluated and found to be satisfactory. The proposed method can be used for simultaneous identification and quantification of the analyzed compounds in pharmaceutical formulations.",
publisher = "AOAC Int, Gaithersburg",
journal = "Journal of AOAC International",
title = "High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals",
volume = "93",
number = "4",
pages = "1121-1128",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1334"
}
Letica, J., Marković, S., Zirojević, J., Nikolić, K.,& Agbaba, D.. (2010). High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals. in Journal of AOAC International
AOAC Int, Gaithersburg., 93(4), 1121-1128.
https://hdl.handle.net/21.15107/rcub_farfar_1334
Letica J, Marković S, Zirojević J, Nikolić K, Agbaba D. High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals. in Journal of AOAC International. 2010;93(4):1121-1128.
https://hdl.handle.net/21.15107/rcub_farfar_1334 .
Letica, Jelena, Marković, Slavko, Zirojević, Jelena, Nikolić, Katarina, Agbaba, Danica, "High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals" in Journal of AOAC International, 93, no. 4 (2010):1121-1128,
https://hdl.handle.net/21.15107/rcub_farfar_1334 .

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