HPLC法测定三磷酸胞苷二钠注射液的有关物质和含量

目的: 建立用HPLC测定三磷酸胞苷二钠注射液的有关物质和含量的方法。方法: 采用C₁₈色谱柱,以含反相离子对试剂的磷酸盐缓冲液为流动相,流速为1.0 mL·min^-1,检测波长为280 nm,柱温30 ℃,有关物质和三磷酸胞苷二钠的含量按峰面积以外标法计算。结果: 三磷酸胞苷二钠浓度在90～1800 mg·L^-1范围内线性关系良好(r=0.9997);平均回收率(n=9)为101.4%;供试品溶液在25 h内的稳定性良好(RSD=0.9%),定量限为7.4 ng。结论: 该方法适用于三磷酸胞苷二钠注射液的质量控制。不同厂家的产品质量存在差异。

Objective: To establish a method of content determination and assay of related substances in cytidine disodium triphosphate (CTP-Na₂) injection by HPLC. Methods: The C₁₈ column was used as the analytical column, the mobile phase was composed of reversed phase ion-pair reagent and phosphate buffer with the flow rate of 1.0 mL·min^-1, the detection wavelength was set at 280 nm, and the column temperature was set at 30 ℃;The content computation was performed with peak area external reference method. Results: The linear range of cytidine disodium triphosphate was 90-1800 mg·L^-1 (r=0.9997), and the recovery rate (n=9) was 101.4%.The sample solution was stable within 25 hours (RSD=0.9%), the limit of quantitation was 7.4 ng. Conclusion: The method can be applied to quality control of cytidine disodium triphosphate.The product quality of different manufacturers has great difference.

1 State Food and Drug Administration Note
[2006] No.67(国食药监注
[2006] 67号).Amendments to the cytidine triphosphate disodium preparation instructions(关于修订三磷酸胞苷二钠制剂说明书的通知)
2 GUO Rui-fang(郭瑞芳),LI Ying-ping(李英平),LI Yu-chen(李玉臣),et al.Effect of sodium cytidine triphosphate on expression of synaptophysin in hippocampal subfields CA3 after focal cerebral ischemia in rats(三磷酸胞苷二钠对脑缺血大鼠海马CA3区突触体素表达的影响).J Apopl Nerv Dis(中风与神经系统杂志),2003,20(6):529
3 The Quality Standards for Drug of China(国家药品标准).National Drug Standard Provincial Standard of Chemical Drugs Up to National Standard(化学药品地方标准上升国家标准).Vol 16(第16册).2002.272
4 LI Da-ping(李大平),CUI Feng-yun(崔凤云).The rapid determination act of cytidine triphosphate disodium(三磷酸胞苷二钠的简易快速测定法).China Pharm(中国药业),2007,16(6):39
5 LI Yao-zeng(李耀曾),MA He-min(马贺民).Determination of cytidine disodium triphosphate injection by celluose acetate membrane electrochromatography dual-wavelength scanning(醋纤膜电泳双波长扫描法测定三磷酸胞苷二钠注射液的含量).Chin J Biochem Pharm(中国生化药物杂志),2004,25(1):34
6 WANG Xiang-hong(王祥洪),YANG Ji-dong(杨季冬).Color reaction of sodium cytidine triphosphate-ethyl violet system and its analytical application(三磷酸胞苷二钠-乙基紫体系的显色反应及其分析应用).J Nanjing Univ(Nat Sci)(南京大学学报自然科学),2011,47(1):97
7 WANG Qiu-xiang(王秋香),JI Hong-wei(季宏伟),ZHANG Yan-tong(张彦彤).Determination of cytidine disodium triphosphate by HPLC(高效液相色谱法测定三磷酸胞苷二钠中的含量).J Changchun Univ Tradit Chin Med(长春中医药大学学报),2007,23(3):26
8 QIAO Hong-qun(乔红群),HE Xue-jun(何学军),ZHANG Ai-qin(张爱琴),et al.Reversed phase ion-pair HPLC determination of cytidine disodium triphosphate in cytidine disodium triphosphate injection(反相离子对HPLC法测定三磷酸胞苷二钠注射液的含量).Chin J Pharm Anal(药物分析杂志),2006,26(8):1132
9 LI Wen-xia(历文霞),SU Yun-ming(苏云明),LI Guo-hui(李国辉).Determination of the related substances in cytidine in disodium triphosphate sodium chloride injection by HPLC(HPLC法测定三磷酸胞苷二钠氯化钠注射液的有关物质).China Pharm(中国药师),2010,13(4):529
10 State Food and Drug Administration Standards(国家食品药品监督管理局标准).YBH10172006
11 State Food and Drug Administration Standards(国家食品药品监督管理局标准).YBH24542006
12 State Food and Drug Administration Standards(国家食品药品监督管理局标准).YBH24472006
13 State Food and Drug Administration Standards(国家食品药品监督管理局标准).YBH04792008