J4 ›› 2016, Vol. 1 ›› Issue (10): 14-17.

• 药学 • 上一篇    下一篇

HPLC测定心脉隆注射液中3组分的含量

  

  1. (云南腾药制药股份有限公司研发部,云南腾冲679100)
  • 收稿日期:2015-07-06 修回日期:2015-10-13 出版日期:2016-10-15 发布日期:2016-10-15
  • 作者简介:邵维在,工程师,主要从事新产品研发、产品工艺优化、中药质量标准研究.

Determination of Three Components in XML Injection by HPLC

  1. (Research and Development Department, Yunnan Tengyao Pharmaceutical Co., Ltd., Tengchong, Yunnan 679100, China)
  • Received:2015-07-06 Revised:2015-10-13 Online:2016-10-15 Published:2016-10-15

摘要:

目的:建立心脉隆注射液中尿嘧啶,次黄嘌呤,肌苷的含量测定方法。方法:采用HPLC法对心脉隆注射剂中3组分进
行含量测定,色谱柱:Agilent C18色谱柱;流动相:0.05 mol/L乙酸钠缓冲液(pH 5.0)为流动相A,甲醇-0.05 mol/L乙酸钠缓冲液
(pH 5.0)(80:20)混合液为流动相B,进行梯度洗脱;流速:0.5 mL/min;检测波长:254 nm;柱温:30 ℃。结果:尿嘧啶,次黄嘌呤,肌
苷分别在0.038~2.404 μg,0.055~3.524 μg,0.089~5.716 μg范围内呈现良好的线性关系,r=0.999 97、r=0.999 94、r=0.999 92;尿
嘧啶平均回收率为99.30%,RSD=1.22%(n=9);次黄嘌呤平均回收率为99.39%,RSD=0.91%(n=9);肌苷平均回收率为99.61%,
RSD=0.93%(n=9)。结论:此法简便、准确,适用于心脉隆注射液中3种成分的同时测定。

关键词: 心脉隆注射液, 尿嘧啶, 次黄嘌呤, 肌苷

Abstract:

Objective: To develop a method for determination of uracil, hypoxanthine and inosine of XML injection. Methods: HPLC
method was adopted in the determination of three components in XML injection. The analysis was performed on an Agilent C18 column
with the mobile phase consisting of 0.05 mol/L sodium acetate buffer solution(A)(pH=5.0), methanol and 0.05 mol/L sodium citrate
butter mixed solution(80:20)(B)(pH=6.5)by gradient elution at a flow rate of 0.5 mL/min. The detection wavelength was set at 254
nm and the column temperature was 30 ℃. Results: The linear ranges were 0.038 to 2.404 μg(r=0.999 97)for uracil, 0.055 to 3.524
μg(r=0.999 94)for hypoxanthine and 0.089 to 5.716 μg(r=0.999 92)for inosine. The average recoveries(n=9)of three components
were 99.30% for uracil, RSD=1.22%; 99.39% for hypoxanthine, RSD=0.91%; and 99.61% for inosine, RSD=0.93%. Conclusion: This
method is simple, convenient and accurate, which is suitable for the quantitative analysis of uracil, hypoxanthine and inosine in the
XML injection.

Key words: XML injection, uracil, hypoxanthine, inosine

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