The Experts below are selected from a list of 33 Experts worldwide ranked by ideXlab platform
Su Zeng - One of the best experts on this subject based on the ideXlab platform.
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determination of enantiomeric impurity in besifloxacin hydrochloride by chiral high performance liquid chromatography with precolumn derivatization
Chirality, 2012Co-Authors: Zhangting Wang, Shengjia Wang, Zaixin Chen, Lushan Yu, Su ZengAbstract:Besifloxacin hydrochloride is a novel chiral broad-spectrum fluoroquinolone developed for the treatment of bacterial conjunctivitis. R-besifloxacin hydrochloride is used in clinics as a consequence of its higher antibacterial activity. To establish an enantiomeric impurity determination method, some chiral stationary phases (CSPs) were screened. Besifloxacin enantiomers can be separated to a certain extent on Chiral CD-Ph (Shiseido Co., Ltd., Japan), Chiral AGP, and Crownpak CR (+) (Daicel Chemical IND., Ltd., Japan). However, the selectivity and sensitivity were both unsatisfactory on these three CSPs. Therefore, Chiral AGP, Chiral CD-Ph, and Crownpak CR (+) were not used in the enantiomeric impurity determination of besifloxacin hydrochloride. The separation of enantiomers of besifloxacin was further performed using a precolumn derivatization chiral high-performance liquid chromatography method. 2,3,4,6-Tetra-O-acetyl-beta-D-glucopyranosyl isothiocyanate was used as the derivatization reagent. Besifloxacin enantiomer derivates were well separated on a C18 column (250 × 4.6 mm, 5 µm) with a mobile phase that consisted of methanol-KH2PO4 buffer solution (20 mM; pH 3.0) (50:50, v/v). Selectivity, sensitivity, linearity, accuracy, precision, stability, and robustness of this method were all satisfied with the method Validation Requirement. The method was suitable for the quality control of enantiomeric impurity in besifloxacin hydrochloride. Chirality 24:526–531, 2012. © 2012 Wiley Periodicals, Inc.
Richard Poska - One of the best experts on this subject based on the ideXlab platform.
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Should Acceptable Product Yield be a Validation Requirement? Validation Case Study #6
2011Co-Authors: Paul L. Pluta, Richard PoskaAbstract:"Validation Case Studies" discusses Validation situa- tions useful to practitioners in Validation and compli- ance. Each case presented deals with a specific vali- dation problem, elements of which are described to demonstrate strategy to solve Validation problems. We intend this column to be a useful resource for daily work applications. Reader comments, questions, and suggestions are needed to help us fulfill our objective for this col- umn. Please send your comments and suggestions to managing editor Susan Haigney at shaigney@ advanstar.com.
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should acceptable product yield be a Validation Requirement Validation case study 6
2011Co-Authors: Paul L. Pluta, Richard PoskaAbstract:"Validation Case Studies" discusses Validation situa- tions useful to practitioners in Validation and compli- ance. Each case presented deals with a specific vali- dation problem, elements of which are described to demonstrate strategy to solve Validation problems. We intend this column to be a useful resource for daily work applications. Reader comments, questions, and suggestions are needed to help us fulfill our objective for this col- umn. Please send your comments and suggestions to managing editor Susan Haigney at shaigney@ advanstar.com.
Zhangting Wang - One of the best experts on this subject based on the ideXlab platform.
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determination of enantiomeric impurity in besifloxacin hydrochloride by chiral high performance liquid chromatography with precolumn derivatization
Chirality, 2012Co-Authors: Zhangting Wang, Shengjia Wang, Zaixin Chen, Lushan Yu, Su ZengAbstract:Besifloxacin hydrochloride is a novel chiral broad-spectrum fluoroquinolone developed for the treatment of bacterial conjunctivitis. R-besifloxacin hydrochloride is used in clinics as a consequence of its higher antibacterial activity. To establish an enantiomeric impurity determination method, some chiral stationary phases (CSPs) were screened. Besifloxacin enantiomers can be separated to a certain extent on Chiral CD-Ph (Shiseido Co., Ltd., Japan), Chiral AGP, and Crownpak CR (+) (Daicel Chemical IND., Ltd., Japan). However, the selectivity and sensitivity were both unsatisfactory on these three CSPs. Therefore, Chiral AGP, Chiral CD-Ph, and Crownpak CR (+) were not used in the enantiomeric impurity determination of besifloxacin hydrochloride. The separation of enantiomers of besifloxacin was further performed using a precolumn derivatization chiral high-performance liquid chromatography method. 2,3,4,6-Tetra-O-acetyl-beta-D-glucopyranosyl isothiocyanate was used as the derivatization reagent. Besifloxacin enantiomer derivates were well separated on a C18 column (250 × 4.6 mm, 5 µm) with a mobile phase that consisted of methanol-KH2PO4 buffer solution (20 mM; pH 3.0) (50:50, v/v). Selectivity, sensitivity, linearity, accuracy, precision, stability, and robustness of this method were all satisfied with the method Validation Requirement. The method was suitable for the quality control of enantiomeric impurity in besifloxacin hydrochloride. Chirality 24:526–531, 2012. © 2012 Wiley Periodicals, Inc.
Paul L. Pluta - One of the best experts on this subject based on the ideXlab platform.
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Should Acceptable Product Yield be a Validation Requirement? Validation Case Study #6
2011Co-Authors: Paul L. Pluta, Richard PoskaAbstract:"Validation Case Studies" discusses Validation situa- tions useful to practitioners in Validation and compli- ance. Each case presented deals with a specific vali- dation problem, elements of which are described to demonstrate strategy to solve Validation problems. We intend this column to be a useful resource for daily work applications. Reader comments, questions, and suggestions are needed to help us fulfill our objective for this col- umn. Please send your comments and suggestions to managing editor Susan Haigney at shaigney@ advanstar.com.
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should acceptable product yield be a Validation Requirement Validation case study 6
2011Co-Authors: Paul L. Pluta, Richard PoskaAbstract:"Validation Case Studies" discusses Validation situa- tions useful to practitioners in Validation and compli- ance. Each case presented deals with a specific vali- dation problem, elements of which are described to demonstrate strategy to solve Validation problems. We intend this column to be a useful resource for daily work applications. Reader comments, questions, and suggestions are needed to help us fulfill our objective for this col- umn. Please send your comments and suggestions to managing editor Susan Haigney at shaigney@ advanstar.com.
Lushan Yu - One of the best experts on this subject based on the ideXlab platform.
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determination of enantiomeric impurity in besifloxacin hydrochloride by chiral high performance liquid chromatography with precolumn derivatization
Chirality, 2012Co-Authors: Zhangting Wang, Shengjia Wang, Zaixin Chen, Lushan Yu, Su ZengAbstract:Besifloxacin hydrochloride is a novel chiral broad-spectrum fluoroquinolone developed for the treatment of bacterial conjunctivitis. R-besifloxacin hydrochloride is used in clinics as a consequence of its higher antibacterial activity. To establish an enantiomeric impurity determination method, some chiral stationary phases (CSPs) were screened. Besifloxacin enantiomers can be separated to a certain extent on Chiral CD-Ph (Shiseido Co., Ltd., Japan), Chiral AGP, and Crownpak CR (+) (Daicel Chemical IND., Ltd., Japan). However, the selectivity and sensitivity were both unsatisfactory on these three CSPs. Therefore, Chiral AGP, Chiral CD-Ph, and Crownpak CR (+) were not used in the enantiomeric impurity determination of besifloxacin hydrochloride. The separation of enantiomers of besifloxacin was further performed using a precolumn derivatization chiral high-performance liquid chromatography method. 2,3,4,6-Tetra-O-acetyl-beta-D-glucopyranosyl isothiocyanate was used as the derivatization reagent. Besifloxacin enantiomer derivates were well separated on a C18 column (250 × 4.6 mm, 5 µm) with a mobile phase that consisted of methanol-KH2PO4 buffer solution (20 mM; pH 3.0) (50:50, v/v). Selectivity, sensitivity, linearity, accuracy, precision, stability, and robustness of this method were all satisfied with the method Validation Requirement. The method was suitable for the quality control of enantiomeric impurity in besifloxacin hydrochloride. Chirality 24:526–531, 2012. © 2012 Wiley Periodicals, Inc.
