Optimisation and validation of a new CE method for the determination of lansoprazole enantiomers in pharmaceuticals
An analytical method based on CZE to determine lansoprazole enantiomers in pharmaceuticals was developed. The primary factors affecting its separation efficiency, which include chiral selector, pH, buffer concentration, capillary temperature and injection time, were optimised. The best results were...
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| Veröffentlicht in: | Electrophoresis 2009-08, Vol.30 (16), p.2940-2946 |
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| container_title | Electrophoresis |
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| creator | Berzas Nevado, Juon José Castañeda Peñalvo, Gregorio Jiménez Sánchez, Juan Carlos Mochón, Manuel Callejón Rodríguez Dorado, Rosa María Villar Navarro, Mercedes |
| description | An analytical method based on CZE to determine lansoprazole enantiomers in pharmaceuticals was developed. The primary factors affecting its separation efficiency, which include chiral selector, pH, buffer concentration, capillary temperature and injection time, were optimised. The best results were obtained by using a background electrolyte consisting of 50 mM phosphate adjusted to pH 2.2, 12 mM β-CD and 5 mM sodium sulphite, in combination with hydrodynamic injection and a 15 kV separation voltage. Detection limits were calculated from baseline noise and found to be 0.64 mg L⁻¹ for the R enantiomer and 0.72 mg L⁻¹ for the S enantiomer. The proposed method was used to analyse three different pharmaceutical preparations with recoveries of 91-102% of the label content. |
| doi_str_mv | 10.1002/elps.200800810 |
| format | Article |
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The primary factors affecting its separation efficiency, which include chiral selector, pH, buffer concentration, capillary temperature and injection time, were optimised. The best results were obtained by using a background electrolyte consisting of 50 mM phosphate adjusted to pH 2.2, 12 mM β-CD and 5 mM sodium sulphite, in combination with hydrodynamic injection and a 15 kV separation voltage. Detection limits were calculated from baseline noise and found to be 0.64 mg L⁻¹ for the R enantiomer and 0.72 mg L⁻¹ for the S enantiomer. 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The primary factors affecting its separation efficiency, which include chiral selector, pH, buffer concentration, capillary temperature and injection time, were optimised. The best results were obtained by using a background electrolyte consisting of 50 mM phosphate adjusted to pH 2.2, 12 mM β-CD and 5 mM sodium sulphite, in combination with hydrodynamic injection and a 15 kV separation voltage. Detection limits were calculated from baseline noise and found to be 0.64 mg L⁻¹ for the R enantiomer and 0.72 mg L⁻¹ for the S enantiomer. The proposed method was used to analyse three different pharmaceutical preparations with recoveries of 91-102% of the label content.</description><subject>2-Pyridinylmethylsulfinylbenzimidazoles - analysis</subject><subject>2-Pyridinylmethylsulfinylbenzimidazoles - chemistry</subject><subject>beta-Cyclodextrins - chemistry</subject><subject>Chiral separation</subject><subject>CZE</subject><subject>Drug Stability</subject><subject>Electrophoresis, Capillary - methods</subject><subject>Hydrogen-Ion Concentration</subject><subject>Lansoprazole</subject><subject>Linear Models</subject><subject>Pharmaceutical Preparations - chemistry</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Stereoisomerism</subject><subject>Sulfides - chemistry</subject><subject>Temperature</subject><issn>0173-0835</issn><issn>1522-2683</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1v1DAQxS0EoqVw5Qg-wSnL-Ds50tVSPlYUqYt6tLzJhDUkcbCzlPLX4yqrhRNII41G_r2n8TxCnjJYMAD-CrsxLThAmYvBPXLKFOcF16W4T06BGVFAKdQJeZTSVwCQlZQPyQmrdMVAlackXY6T731ykw8DdUNDf7jON_MYWurogDd0uaI9TrvQ0DZEOu2QNjhh7P1wBDs3pDBG9yt0SHFwQ37oMSbqBzruXOxdjfvJ165Lj8mDNjd8cuhnZPNmtVm-LdaXF--Wr9dFLYWBoq44N86AxrxsBToPZVU7qZVUDYJqGu22Sja1kSUaXkLpdGu2jUSs0NTijLycbccYvu8xTTb_s8Yub4phn6wRMh-IK53JF_8khQJuBKgMLmawjiGliK0do-9dvLUM7F0e9i4Pe8wjC54dnPfbHps_-CGADFQzcOM7vP2PnV2tP139bV7MWp8m_HnUuvjNaiOMstcfL-yH91fnm831uRWZfz7zrQvWfYk-2c_Zjglg2kgOXPwG-0mxQA</recordid><startdate>200908</startdate><enddate>200908</enddate><creator>Berzas Nevado, Juon José</creator><creator>Castañeda Peñalvo, Gregorio</creator><creator>Jiménez Sánchez, Juan Carlos</creator><creator>Mochón, Manuel Callejón</creator><creator>Rodríguez Dorado, Rosa María</creator><creator>Villar Navarro, Mercedes</creator><general>Wiley-VCH Verlag</general><general>WILEY-VCH Verlag</general><general>WILEY‐VCH Verlag</general><scope>FBQ</scope><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U5</scope><scope>8FD</scope><scope>L7M</scope><scope>7X8</scope></search><sort><creationdate>200908</creationdate><title>Optimisation and validation of a new CE method for the determination of lansoprazole enantiomers in pharmaceuticals</title><author>Berzas Nevado, Juon José ; 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| source | Wiley Online Library - AutoHoldings Journals; MEDLINE |
| subjects | 2-Pyridinylmethylsulfinylbenzimidazoles - analysis 2-Pyridinylmethylsulfinylbenzimidazoles - chemistry beta-Cyclodextrins - chemistry Chiral separation CZE Drug Stability Electrophoresis, Capillary - methods Hydrogen-Ion Concentration Lansoprazole Linear Models Pharmaceutical Preparations - chemistry Reproducibility of Results Sensitivity and Specificity Stereoisomerism Sulfides - chemistry Temperature |
| title | Optimisation and validation of a new CE method for the determination of lansoprazole enantiomers in pharmaceuticals |
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