CAJ | 학술논문

以双[-6-氧-（-3-间硝基苯磺酰基-丁二酸-1，4单酯）-4-]-β-环糊精键合全多孔硅胶基质为高效液相色谱固定相，以正相和反相模式对药物扑尔敏进行手性分离．考察了流动相中配比、pH值对分离度的影响．结果表明：正相模式最佳条件下分离度Rs=1．37；反相模式最佳条件下分离度Rs=10．58，扑尔敏浓度为0．000～1．367mg／mL，前后峰峰高与浓度均呈线性关系，线性相关系数r均为0．9985．峰面积与浓度的线性相关系数r均为0．9998．通过精密度试验考察，以峰高为响应信号，相对标准偏差RSD（n=12）为2．90％-3．77％；以峰面积为响应信号RSD（n=12）为1．05％-3．15％．加标浓度与样品浓度相当时，以峰高为响应信号，回收率94．69％～106．93％．研究表明，采取反相分离模式，易实现扑尔敏两异构体的分离．
이쌍[-6-양-（-3-간초기분광선기-정이산-1，4단지）-4-]-β-배호정건합전다공규효기질위고효액상색보고정상，이정상화반상모식대약물복이민진행수성분리．고찰료류동상중배비、pH치대분리도적영향．결과표명：정상모식최가조건하분리도Rs=1．37；반상모식최가조건하분리도Rs=10．58，복이민농도위0．000～1．367mg／mL，전후봉봉고여농도균정선성관계，선성상관계수r균위0．9985．봉면적여농도적선성상관계수r균위0．9998．통과정밀도시험고찰，이봉고위향응신호，상대표준편차RSD（n=12）위2．90％-3．77％；이봉면적위향응신호RSD（n=12）위1．05％-3．15％．가표농도여양품농도상당시，이봉고위향응신호，회수솔94．69％～106．93％．연구표명，채취반상분리모식，역실현복이민량이구체적분리．
Chiral separation of chlorpheniramine was investigated by HPLC with silica gels bonded his [ 6-oxygen-（3-m- nitrobenzene sulfonyl-amber acid-I, 4uniester-4） ] - β-CD as stationary phase. The effects of organic phase concentration and buffer pH in mobile phase were discussed. The best conditions for the normal phase mode HPLC separation was obtained with resolution R, of 1.37. Under reversed phase（RP） mode separation, the R, of optimum conditions is 10.58. There were good linear relationship within concentration range of chlorpheniramine from 0. 000 to 1. 367 mg/mL in peak area and peak height, linear correlation coefficients all are 0. 9985 and 0. 9998. Precision test： the relative standard deviation RSD （n = 12） is 2.90 % - 3.77 % （ peak height） and 1.05 % -3.15 % （ peak area）. Recovery test： the percent recovery is 94.69 % - 106.93 % （ peak height） when it is the same concentration of the sample and the addition. The experiment result shows that： in RP mode, enantiomers were separated on baseline.