高效液相色谱法测定莪术油葡萄糖注射液的稳定性
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何海冰， 唐 星
(沈阳药科大学药学院，辽宁 沈阳 110016)
摘要：目的 建立莪术挥发油中吉马酮高效液相色谱含量测定方法，并用此方法对莪术油葡萄糖注射液进行稳定性考察。方法 含量测定采用HPLC法。选用ODS C18柱(5 µm，4.6 mm×200 mm)，流动相为甲醇-水(80:20)，流速0.8 mL·min-1，测定波长204 nm。稳定性研究采用高温加速试验法。结果 吉马酮进样量在0.496～3.968 µg内线性关系良好(r=0.999 9)，平均回收率101.0%，RSD为1.78%(n=9)。用HPLC法和药典方法考察自制莪术油葡萄糖注射液的降解t1/2分别为21.52 h和12.05 h。结论 HPLC法能很好地分离检测莪术油中的吉马酮，可用于莪术油原料及制剂的含量测定；自制莪术油葡萄糖注射液的稳定性较差。
关键词： 药剂学；稳定性；含量测定；高温加速试验法；高效液相色谱法；莪术油注射液
中图分类号：R94 文献标识码：A
Determination of stability of glucose injection of Rhizoma curcumae oil by HPLC method
HE Hai-bing，TANG Xing
(School of pharmacy，Shenyang Pharmaceutical University，Shenyang 110016，China)
Abstract: Objective To develop a method for the determination of germacrone in volatile oil of Rhizoma curcumae and inspect the stability of glucose injection of Rhizoma curcumae oil. Methods An HPLC method was developed. ODS C18 column was used in HPLC with mobile phase:MeOH-water (80:20), detection wavelength:204 nm. high temperature acceleration method was used to study the stability. Results The linear range of HPLC is from 0.496 to 3.968 μg (r=0.999 9). The average recovery is 101.0%, RSD=1.78% (n=9). Degradation T1/2 of preparation are 21.52 h and 12.05 h ,respectively, by HPLC and UV methods. Conclusion This method is reliable, accurate and suitable for the determination of germacrone in the volatile oil and the stability of glucose injection of Rhizoma curcumae oil is poor.
Key words: pharmaceutics; stability; content determination; high temperature acceleration method; HPLC; Rhizoma curcumae oil injection
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