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