HPLC法测定盐酸阿扎司琼氯化钠注射液的含量.doc

文档介绍：HPLC法测定盐酸阿扎司琼氯化钠注射液的含量
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【摘要】目的建立了盐酸阿扎司琼氯化钠注射液含量的HPLC测定法。方法采用C18色谱柱,-甲醇(60:40)(±)为流动相,检测波长305nm。~,%(RSD=%)。结论采用HPLC法测定盐酸阿扎司琼氯注射液的含量,专属性强、重现性好。
【关键词】盐酸阿扎司琼;HPLC;测定
【Abstract】 Objective To establish the HPLC method for the determination of Azasetron Hydrochlorioc acid and Sodium Chloride A C18 column was used with a mixture of sodium dihydrogen phosphate-methanol(60:40) as the mobile detection wavelength was 305nm. Results It had a good linearity over the concertration range of ~
μg. The average recovery was % with RSD of %.Conclusion The method for the determination of Azasetron Hydrochloric acid and sodium chloride injection by HPLC was specificity and reproducibility.
【Key words】 azasetron hydrochloride;HPLC;determination
盐酸阿扎司琼(Azasetron Hydrochloride)属于新型高选择性5-HT受体阻滞剂,能迅速有效地防治恶性肿瘤患者在应用铂类等抗癌药时出现的恶心、呕吐,且不产生锥体外系症状。我公司研制的盐酸阿扎司琼氯化钠注射液(国药准字H20041989)质量稳定可控。本实验采用反相高效液相色谱法测定盐酸阿扎司琼的含量,该法专属性强,重现性好。
1 仪器与试药
仪器岛津高效液相色谱仪,LC-10AD溶剂输送泵, SPD-10A紫外检测器, C-R6A数据处理机,Rheodyne7125进样阀,METTLER AG245电子天平(精度十万分之一)。
试药盐酸阿扎司琼氯化钠注射液(扬子江药业集团有限公司试制,规格:50ml: 。批号:020911、020913、020916);甲醇为色谱纯,其他试剂均为分析纯。
2 方法与结果
色谱条件与系统适用性实验色谱柱Shim-pack CLC-ODS柱(
×250mm,5μm);-甲醇(6