CAJ | 학술논문

目的：建立肾上腺素光学异构体中 S-对映体的高效液相色谱手性流动相检测方法。方法 Purospher? STAR RP-18色谱柱(4.6 mm×250 mm,5μm),流动相：10 mmol·L-1磷酸二氢钠缓冲液(含10 mmol·L-1手性添加剂磺丁基-b-环糊精,磷酸调节 pH 至3.0)-乙腈(98.5：1.5),流速0.8 mL·min-1,柱温30℃,检测波长280 nm。结果肾上腺素 S-对映体在浓度5.02~501.50μg · mL-1范围内与峰面积呈良好的线性关系,相关系数0.9997,检测限0.05μg·mL-1。结论该方法重复性、耐用性好,适用于盐酸肾上腺素注射液中 S-对映体杂质含量的测定。
목적：건립신상선소광학이구체중 S-대영체적고효액상색보수성류동상검측방법。방법 Purospher? STAR RP-18색보주(4.6 mm×250 mm,5μm),류동상：10 mmol·L-1린산이경납완충액(함10 mmol·L-1수성첨가제광정기-b-배호정,린산조절 pH 지3.0)-을정(98.5：1.5),류속0.8 mL·min-1,주온30℃,검측파장280 nm。결과신상선소 S-대영체재농도5.02~501.50μg · mL-1범위내여봉면적정량호적선성관계,상관계수0.9997,검측한0.05μg·mL-1。결론해방법중복성、내용성호,괄용우염산신상선소주사액중 S-대영체잡질함량적측정。
Objective To establish a method for the chiral separation and determination of S-isomer in epinephrine hydrochloride injection by HPLC with chiral mobile phase additives. Methods Column of Purospher? STAR RP-18 (4. 6 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-10 mmol·L-1 sodium dihydrogen phosphate buffer containing 10 mmol·L-1 sulfobutylether-b-cyclodextrin (pH adjusted to 3. 0 with phosphoric acid) (98. 5:1. 5), detection wavelength was 280 nm, the flow rate was 0. 8 mL·min-1 , and the column temperature was 30 ℃ . Results Good linear relationship was established between the peak area and the concentration of S-isomer over the range of 5. 02-1501. 50 μg·mL-1 (R2 =0. 999 7). The detection limit was 0. 05 μg·mL-1 . Conclusion The proposed method shows high repeatability and durability. It can be employed for the quality control of S-isomer in epinephrine hydrochloride injection.