Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities
Апстракт
The main objective of the work discussed in this paper was evaluation of a chromatographic method for simultaneous determination of hydrochlorothiazide (HCTZ), lisinopril (L), and their impurities in pharmaceuticals. Chlorothiazide (CTZ) and disulfonamide (DSA), as potential impurities in hydrochlorothiazide, and diketopiperazine (DKP), as an impurity of lisinopril, were analyzed. The chromatographic behaviour of these substances on different columns was studied using mobile phases of different polarity. The optimum separations were achieved by gradient elution on a 4.6 mm x 20 mm, 3.5 mu m particle size, C-18 column. The mobile phase was a gradient prepared by mixing 7:93 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate, pH 5, and 50:50 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate pH 5 in different ratios. The flow rate was 1.0 mL min(-1). UV detection was performed at 215 nm. Methylparaben was used as internal standard. The method was validated for selectivity, line...arity, precision,. and accuracy. The limits of detection, LOD, and quantification, LOQ, were determined experimentally. Because of its speed and accuracy the method can be used for quality-control analysis.
Извор:
Acta Chromatographica, 2007, 18, 143-156Издавач:
- Univ Silesia, Inst Chemistry, Katowice
Институција/група
PharmacyTY - JOUR AU - Ivanović, D. AU - Medenica, Mirjana AU - Jančić, Biljana AU - Knežević, N. AU - Malenović, Anđelija AU - Milić, J. PY - 2007 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/964 AB - The main objective of the work discussed in this paper was evaluation of a chromatographic method for simultaneous determination of hydrochlorothiazide (HCTZ), lisinopril (L), and their impurities in pharmaceuticals. Chlorothiazide (CTZ) and disulfonamide (DSA), as potential impurities in hydrochlorothiazide, and diketopiperazine (DKP), as an impurity of lisinopril, were analyzed. The chromatographic behaviour of these substances on different columns was studied using mobile phases of different polarity. The optimum separations were achieved by gradient elution on a 4.6 mm x 20 mm, 3.5 mu m particle size, C-18 column. The mobile phase was a gradient prepared by mixing 7:93 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate, pH 5, and 50:50 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate pH 5 in different ratios. The flow rate was 1.0 mL min(-1). UV detection was performed at 215 nm. Methylparaben was used as internal standard. The method was validated for selectivity, linearity, precision,. and accuracy. The limits of detection, LOD, and quantification, LOQ, were determined experimentally. Because of its speed and accuracy the method can be used for quality-control analysis. PB - Univ Silesia, Inst Chemistry, Katowice T2 - Acta Chromatographica T1 - Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities VL - 18 SP - 143 EP - 156 UR - https://hdl.handle.net/21.15107/rcub_farfar_964 ER -
@article{ author = "Ivanović, D. and Medenica, Mirjana and Jančić, Biljana and Knežević, N. and Malenović, Anđelija and Milić, J.", year = "2007", abstract = "The main objective of the work discussed in this paper was evaluation of a chromatographic method for simultaneous determination of hydrochlorothiazide (HCTZ), lisinopril (L), and their impurities in pharmaceuticals. Chlorothiazide (CTZ) and disulfonamide (DSA), as potential impurities in hydrochlorothiazide, and diketopiperazine (DKP), as an impurity of lisinopril, were analyzed. The chromatographic behaviour of these substances on different columns was studied using mobile phases of different polarity. The optimum separations were achieved by gradient elution on a 4.6 mm x 20 mm, 3.5 mu m particle size, C-18 column. The mobile phase was a gradient prepared by mixing 7:93 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate, pH 5, and 50:50 (v/v) acetonitrile-25 mm potassium dihydrogen phosphate pH 5 in different ratios. The flow rate was 1.0 mL min(-1). UV detection was performed at 215 nm. Methylparaben was used as internal standard. The method was validated for selectivity, linearity, precision,. and accuracy. The limits of detection, LOD, and quantification, LOQ, were determined experimentally. Because of its speed and accuracy the method can be used for quality-control analysis.", publisher = "Univ Silesia, Inst Chemistry, Katowice", journal = "Acta Chromatographica", title = "Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities", volume = "18", pages = "143-156", url = "https://hdl.handle.net/21.15107/rcub_farfar_964" }
Ivanović, D., Medenica, M., Jančić, B., Knežević, N., Malenović, A.,& Milić, J.. (2007). Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities. in Acta Chromatographica Univ Silesia, Inst Chemistry, Katowice., 18, 143-156. https://hdl.handle.net/21.15107/rcub_farfar_964
Ivanović D, Medenica M, Jančić B, Knežević N, Malenović A, Milić J. Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities. in Acta Chromatographica. 2007;18:143-156. https://hdl.handle.net/21.15107/rcub_farfar_964 .
Ivanović, D., Medenica, Mirjana, Jančić, Biljana, Knežević, N., Malenović, Anđelija, Milić, J., "Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities" in Acta Chromatographica, 18 (2007):143-156, https://hdl.handle.net/21.15107/rcub_farfar_964 .