中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
4期
652-655
,共4页
注射用单磷酸阿糖腺苷%有关物质%阿糖腺苷%腺嘌呤%高效液相色谱%杂质检测
註射用單燐痠阿糖腺苷%有關物質%阿糖腺苷%腺嘌呤%高效液相色譜%雜質檢測
주사용단린산아당선감%유관물질%아당선감%선표령%고효액상색보%잡질검측
Vidarabine monophosphate for injection%Related substances%Vidarabine%Adenine%HPLC%Impurity assay
目的:建立测定注射用单磷酸阿糖腺苷中有关物质的高效液相色谱法。方法:采用Kromasil 100-5 C18(250 mm ×4.6 mm,5μm)色谱柱,以水(含10 mmol·L-1四丁基氢氧化铵与10 mmol·L-1磷酸二氢钾)-甲醇(80:20)为流动相;流速为1.0 ml·min-1,检测波长:258 nm,柱温:30℃;进样量:20μl;应用外标法对注射用单磷酸阿糖腺苷中已知杂质阿糖腺苷和腺嘌呤进行检查,其他未知杂质用主成分自身对照法进行检查。结果:阿糖腺苷和腺嘌呤分别在0.0765~1.5307μg·ml-1(r=0.9999),0.0780~1.560 0μg·ml-1(r=0.9999)范围内线性关系良好,平均回收率分别为99.8%(RSD=0.2%,n=9)、97.0%(RSD=1.2%,n=9)。结论:该方法可用于注射用单磷酸阿糖腺苷有关物质的测定。
目的:建立測定註射用單燐痠阿糖腺苷中有關物質的高效液相色譜法。方法:採用Kromasil 100-5 C18(250 mm ×4.6 mm,5μm)色譜柱,以水(含10 mmol·L-1四丁基氫氧化銨與10 mmol·L-1燐痠二氫鉀)-甲醇(80:20)為流動相;流速為1.0 ml·min-1,檢測波長:258 nm,柱溫:30℃;進樣量:20μl;應用外標法對註射用單燐痠阿糖腺苷中已知雜質阿糖腺苷和腺嘌呤進行檢查,其他未知雜質用主成分自身對照法進行檢查。結果:阿糖腺苷和腺嘌呤分彆在0.0765~1.5307μg·ml-1(r=0.9999),0.0780~1.560 0μg·ml-1(r=0.9999)範圍內線性關繫良好,平均迴收率分彆為99.8%(RSD=0.2%,n=9)、97.0%(RSD=1.2%,n=9)。結論:該方法可用于註射用單燐痠阿糖腺苷有關物質的測定。
목적:건립측정주사용단린산아당선감중유관물질적고효액상색보법。방법:채용Kromasil 100-5 C18(250 mm ×4.6 mm,5μm)색보주,이수(함10 mmol·L-1사정기경양화안여10 mmol·L-1린산이경갑)-갑순(80:20)위류동상;류속위1.0 ml·min-1,검측파장:258 nm,주온:30℃;진양량:20μl;응용외표법대주사용단린산아당선감중이지잡질아당선감화선표령진행검사,기타미지잡질용주성분자신대조법진행검사。결과:아당선감화선표령분별재0.0765~1.5307μg·ml-1(r=0.9999),0.0780~1.560 0μg·ml-1(r=0.9999)범위내선성관계량호,평균회수솔분별위99.8%(RSD=0.2%,n=9)、97.0%(RSD=1.2%,n=9)。결론:해방법가용우주사용단린산아당선감유관물질적측정。
Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.