药学与临床研究
藥學與臨床研究
약학여림상연구
PHARMACEUTICAL AND CLINICAL RESEARCH
2014年
6期
516-518
,共3页
邹泓%李迩娜%武婷婷%杨义芳%狄斌
鄒泓%李邇娜%武婷婷%楊義芳%狄斌
추홍%리이나%무정정%양의방%적빈
HPLC法%阿扎胞苷%有关物质
HPLC法%阿扎胞苷%有關物質
HPLC법%아찰포감%유관물질
HPLC%Azacitidine%Related substances
目的:建立阿扎胞苷有关物质的HPLC测定方法。方法:采用Waters Atlantis T3柱(150 mm×4.6 mm,3μm)对降解杂质和工艺杂质进行定量分析。以磷酸二氢钾缓冲液(pH=6.5)-60%乙腈为流动相,梯度洗脱;检测波长为214 nm。结果:主峰与各杂质峰间能达到基线分离。阿扎胞苷浓度在0.271~16.242μg·mL-1范围内与峰面积呈良好的线性关系(r=0.9999),最低检测限为150 ng·mL-1。结论:应用高效液相色谱法选择性高、重现性好,可作为阿扎胞苷质量控制的方法。
目的:建立阿扎胞苷有關物質的HPLC測定方法。方法:採用Waters Atlantis T3柱(150 mm×4.6 mm,3μm)對降解雜質和工藝雜質進行定量分析。以燐痠二氫鉀緩遲液(pH=6.5)-60%乙腈為流動相,梯度洗脫;檢測波長為214 nm。結果:主峰與各雜質峰間能達到基線分離。阿扎胞苷濃度在0.271~16.242μg·mL-1範圍內與峰麵積呈良好的線性關繫(r=0.9999),最低檢測限為150 ng·mL-1。結論:應用高效液相色譜法選擇性高、重現性好,可作為阿扎胞苷質量控製的方法。
목적:건립아찰포감유관물질적HPLC측정방법。방법:채용Waters Atlantis T3주(150 mm×4.6 mm,3μm)대강해잡질화공예잡질진행정량분석。이린산이경갑완충액(pH=6.5)-60%을정위류동상,제도세탈;검측파장위214 nm。결과:주봉여각잡질봉간능체도기선분리。아찰포감농도재0.271~16.242μg·mL-1범위내여봉면적정량호적선성관계(r=0.9999),최저검측한위150 ng·mL-1。결론:응용고효액상색보법선택성고、중현성호,가작위아찰포감질량공제적방법。
Objective: To esta blish a HPLC method for the determination of the related substances of azacitidine. Methods: The separation for degradation and process impurities was based on a Waters At_lantis T3 (150 mm ×4.6 mm, 3μm) column; the Mobile phase contisted of potassium dihydrogen phosphate solution (adjust to pH 6.5)-60%acetonitrile with gradient elution; the detective wavelength was 214 nm. Re_sults: The chief peak and every impurity peak were separated well. A good linearity for azacitidine was obtained over the range of 0.2707~16.2420μg·mL-1 (r=0.9999), the LOD was 150 ng·mL-1. Conclusion:This highly selective and reproducible HPLC method offers an option in the quality control of azacitidine.