High-Performance Liquid Chromatographic Determination of Pantoprazole and Its Main Impurities in Pharmaceuticals
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, 1121-1128Publisher:
- AOAC Int, Gaithersburg
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PharmacyTY - 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 .