HPLC法测定注射用盐酸阿糖胞苷的含量及有关物质  

HPLC determination of cytarabine hydrochloride for injection and its related substances

作　　者：刘茜[1] 潘维芳[1] 吴颖[1] 吴小虎[1] 陈桂良[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《药物分析杂志》2007年第9期1411-1415,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立同时测定注射用盐酸阿糖胞苷的含量及有关物质的 HPLC 方法。方法:采用 Agilent 1100型高效液相色谱仪,以 Waters ODS(4.6 mm×150 mm,5μm)为色谱柱,流动相:甲醇-5 mmol·L^(-1)戊烷磺酸钠溶液(用冰醋酸调节 pH 至2.8)(7:93),流速:1.0 mL·min^(-1),检测波长:280 nm,进样量:40μL。结果:盐酸阿糖胞苷浓度在9.983～199.7μg·mL^(-1)范围内呈良好的线性关系,r=0.9998;加样半均回收率(n=9)为100.5%;测定盐酸阿糖胞苷的最小检出量为0.33 ng。结论:本方法准确可靠,专属性强,灵敏度高,可用于盐酸阿糖胞苷的质量控制。Objective：To establish an HPLC method for the analysis of cytarabine hydrochloride for injection and its related substances. Methods ：The HPLC method was performed on an Agilent 1100 liquid chromatography. Waters ODS column（4. 6 mm × 150 mm,5 μm） was used with the mobile phase of methanol -5 mmol · L^-1 sodium pentanesulfonate solution （ adjusting the pH to 2. 8 with glacial acetic acid） （7：93 ）. The flow rate was 1.0 mL · min^ - 1 and the detection wavelength was set at 280 nm. Results： A linearity between peak area and cytarabine hydrochloride concentration was achieved in the range of 9. 983 - 199. 7 μg · mL^-1 with r of 0. 9998. The average recovery（n =9） was 100. 5%. The lowest detectable amount was 0. 33 ng. Conclusion：The method is accurate,specific, sensitive and can be used for quality control of cytarabine hydrochloride for injection.

关 键 词：注射用盐酸阿糖胞苷 含量测定 有关物质 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]