Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase
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Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase
Vol. 33, Issue 10, Pages: 1123-1128(2014)
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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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Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase. [J]. 33(10):1123-1128(2014)
DOI:
Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase. [J]. 33(10):1123-1128(2014)DOI:
Simultaneous Determination of Enantiomer and Diastereomers in Solifenacin Succinate Bulk Drug by High Performance Liquid Chromatography with Chiral Stationary Phase
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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