CAJ | 학술논문

目的：建立5-氨基水杨酸灌肠液的含量及其有关物质的测定方法。方法：采用高效液相色谱梯度洗脱法测定,色谱柱为Hypersil,ODS C18(250 mm ×4.6 mm,5.0μm),流动相为流动相A为pH 7.5磷酸缓冲液(PBS)∶四丁基氢氧化铵溶液( TBAH)∶甲醇∶水(600∶50∶50∶300)；流动相B为pH 7.5磷酸缓冲液∶TBAH∶甲醇∶水(200∶50∶300∶450)。检测波长为208 nm；柱温40℃,进样量20μl。结果：5-氨基水杨酸与其两种降解产物可完全分离。5-氨基水杨酸在1~250μg·ml-1的浓度范围内,浓度与峰面积具有良好的线性关系,r=0.9995,平均回收率为99.44%,RSD为0.94%(n=9)。结论：方法简单、灵敏、重复性好,可用于本品的含量和有关物质检查。
목적：건립5-안기수양산관장액적함량급기유관물질적측정방법。방법：채용고효액상색보제도세탈법측정,색보주위Hypersil,ODS C18(250 mm ×4.6 mm,5.0μm),류동상위류동상A위pH 7.5린산완충액(PBS)∶사정기경양화안용액( TBAH)∶갑순∶수(600∶50∶50∶300)；류동상B위pH 7.5린산완충액∶TBAH∶갑순∶수(200∶50∶300∶450)。검측파장위208 nm；주온40℃,진양량20μl。결과：5-안기수양산여기량충강해산물가완전분리。5-안기수양산재1~250μg·ml-1적농도범위내,농도여봉면적구유량호적선성관계,r=0.9995,평균회수솔위99.44%,RSD위0.94%(n=9)。결론：방법간단、령민、중복성호,가용우본품적함량화유관물질검사。
Objective:To establish an HPLC method to determine 5-amino salicylic acid (5-ASA) and its related substances in the enemas. Methods:The liquid chromatograph was equipped with a Hypersil ODS C18 column (250 mm × 4. 6 mm,5. 0 μm) with gradient elution. The mobile phase A was composed of pH 7. 5 phosphate buffer ( PBS), tetrabutyl ammonium hydroxide solution (TBAH), methanol and water (600∶50∶50∶300), the mobile phase B was composed of pH 7. 5 PBS, TBAH, methanol and water (200∶50∶300∶450). The wavelength was 208nm, the column temperature was 40 ℃ and the injection volume was 20μl. Results:5-ASA and its two degradation products could be completely separated. The concentration of 5-ASA and the corresponding peak area had a good linear relationship within the range of 1-250μg·ml-1(r=0. 999 5). The average recovery was 99. 44%(RSD=0. 94%,n=9). Conclusion:The method is simple, sensitive and reproducible, and can be used in the determination of the content and related substances in the enemas.