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| Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase |
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| DOI：10.3969/j.issn.1004-4957.年份.月份 |
| KeyWord:solifenacin succinate high performance liquid chromatography(HPLC) enantiomer diastereoisomer |
| Author | Institution |
| WANG Dong-wu，WANG Xi-ning，FENG Mei-jun，SONG Ying-xue |
迪沙药业集团国家认定企业技术中心质量研究院 |
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| Abstract: |
| A normal high performance liquid chromatography(HPLC) with chiral stationary phase for detection of enantiomer and diastereomers in solifenacin succinate bulk drug was developed.The separation efficiencies of Daicel CHIRALPAK? AD-H column，Daicel CHIRALCEL? OJ-H column，Research ＆ Cretivity SCDP52546 column and Research ＆ Cretivity RC-OD52546 column for 4 optical isomers were investigated.Various UV detection wavelengths，column temperatures and mobile phases types were also investigated.The best chromatographic conditions were as follows:column:Daicel CHIRALPAK? AD-H column，mobile phase:n-haxane-ethanol-diethylamide（900∶100∶1），UV detection wavelength:220 nm，flow rate:1 mL/min，column temperature:30 ℃.The method had a good specificity（resolution（R）≥2.0） and a good precision（RSD≤2.0%，n=6）.The calibration curves showed good linearities over the ranges of 0.240 5-10.822 5 μg/mL for enantisomer，0.186 8-8.406 0 μg/mL for diastereoisomerⅠand 0.196 1-8.824 5 μg/mL for diastereoisomerⅡ with correction coefficients more than 0.999.The limits of detection（LODs） were in the range of 0.062 25-0.080 13 μg/mL and the limits of quantitation(LOQs) were 0.186 8-0.240 5 μg/mL.The average spiked recoveries were in the range of 94.4%-95.7% with relative standard deviations of 2.5%-3.1%.The method was simple，sensitive and valid，and could satisfy the requirements for detection of enatiomer and diastereoisomers in solifenacin succinate drug substance. |
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