摘要
目的建立匹多莫德片有关物质检查的方法。方法色谱柱Agilent zorbax NH2（250×4.6mm,5μm）0.01mol·L-1磷酸二氢铵（用10%磷酸调节pH 3.0）-乙腈梯度洗脱,流速1.0mL·min-1-1,检测波长210nm。结果四噻唑烷羧酸、L-焦谷氨酸、杂质X、杂质Y浓度分别在5.665-56.65μg·mL-1、6.040-60.40μg·mL-1、6.032-60.32μg·mL-1、5.940-59.40μg·mL-1内与对应峰面积呈良好的线性关系;相关系数均大于0.9991。结论该方法可作为匹多莫德片有关物质检查的研究。
OBJECTIVE To establish a testing method of Pidotimod Tablets＇ related substances. METHODS The samples were separated on an Agilent zorbax NH2（ 250 ×4.6mm,5μm） ccolunm by gradient elution using acetonitrile-0. 01 mo · L- 1ammonium phosphate monobasic（ adjusted pH to 3. 0 with 10% phosphoric acid）. RESULTS L-4-Thiazolidinecarboxylic acid、L-Pyroglutamic acid、Pidotimod Diketopiperazine-6-propanoic acid and Pidotimod Diketopiperazine had good liner relationship in the range of（ 5. 665 - 56. 65） 、（ 6. 040 - 60. 40） 、（ 6. 032 - 60. 32） and（ 5. 940 - 59.40） μg·mL- 1,respectively. The correlation coefficinets were all more than0. 9991. CONCLUSION The method can be used for the quality control of pidotimod tablets＇ related substances.
出处
《海峡药学》
2014年第8期40-42,共3页
Strait Pharmaceutical Journal
