HPLC-RID法测定冠心宁注射液中三种糖的含量

Determination of Three Kinds of Sugar Compositions in Guan-Xin-Ning Injection by HPLC-RID

目的：建立高效液相色谱联用示差折光检测器测定冠心宁注射液中果糖、葡萄糖和蔗糖含量的方法.方法：Hanbon Lichrospher NH2分析色谱柱（5μm,4.6×250 mm）,Welchrom氨基保护柱（5μm,10 mm×4.6 mm）,流动相为乙腈—水（70∶30）,柱温：30℃,流速：1.0 ml/min,示差折光检测器设定温度：35℃.结果：回归方程A果糖=85 539C＋677.38,r=0.999 9,A葡萄糖=84 012 C＋575.37,r=1,A蔗糖=187 714C＋504.15,r=1（n=6）,果糖浓度在33.72~1 079μg/ml之间、葡萄糖浓度在32.22~1 031μg/ml之间以及蔗糖浓度在16.19~518μg/ml之间线性关系良好;平均回收率分别为100.1%、100.6%和99.3%,RSD分别为1.99、2.35和2.84%（n=6）;注射液中果糖、葡萄糖和蔗糖的总含量占固含物的55.03%.结论：该方法简便快速、准确可靠,可用于冠心宁注射液中果糖、葡萄糖及蔗糖的含量测定.

The present study is to establish the HPLC-RID method which is used to determine the contents of fructose,glucose and sucrose in Guan-Xin-Ning（GXN） injection.The chromatographic conditions were as follows：Hanbon Lichrospher NH2column（5 μm,250 × 4.6 mm） and Welchrom NH2 protection column（5 μm,10 mm ×4.6 mm） with the temperature of 30 ℃,acetonitrile-water（70∶ 30,V/V） as a mobile phase with the flow rate of1.0 m L/min,refractive index detector（RID） at 35 ℃.The results showed that the regression equations of fructose,glucose and sucrose were separately Afructose= 85 539 C ＋ 677.38,r = 0.999 9,Aglucose= 84 012 C ＋ 575.37,r =1 and Asucrose= 187 714 C ＋ 504.15,r = 1（n = 6）.Their linear ranges were 33.72 ~ 1 079 μg/ml,32.22 ~ 1 031μg/ml and 16.19 ~ 518 μg/ml,respectively.The average recoveries and RSDs of the three kinds of sugar compositions were 100.1%,100.6%,99.3% and 1.99,2.35,2.84%（n = 6） in turn.The total content of fructose,glucose and sucrose accounted for 55.03% of solid substance in GXN injection.It is concluded that the approach is simple,rapid,accurate and reliable,which can be applied as the determinations of fructose,glucose and sucrose in GXN injection.