HPLC-RID法同时测定小儿氨酚烷胺颗粒中对乙酰氨基酚及盐酸金刚烷胺的含量  

Determination of Contents of Pediatric Paracetamol and Amantadine Hydrochloride Granules by Using HPLC-RID Method

作　　者：李娜 高毓涛 LI Na GAO Yutao(Liaoning ludan Pharmaceutical Co. Ltd., Dandong, Liaoning 118002, China Dandong City Drug Inspection Test Center, Danclong , Liaoning 118002, China)

机构地区：[1]辽宁绿丹药业有限公司,辽宁丹东118002 [2]丹东市药品检验检测中心,辽宁丹东118002

出　　处：《今日药学》2017年第9期609-611,619,共4页Pharmacy Today

摘　　要：目的建立同时测定小儿氨酚烷胺颗粒中对乙酰氨基酚及盐酸金刚烷胺含量的高效液相色谱-示差折光检测(HPLCRID)法。方法采用Waters Sun Fire C_(18)色谱柱(4.6 mm×150 mm,5μm),流动相为甲醇-水(10∶90,V/V),柱温为30℃,进样量为20μL,流速为1.5 mL·min^(-1),检测器为RID,检测池温度为30℃。结果对乙酰氨基酚的线性范围为0.618 5~4.948 0mg·mL^(-1)(r=0.999 9),平均回收率为99.5%(RSD=1.8%,n=9),盐酸金刚烷胺的线性范围为0.253 2~2.025 6 mg·mL^(-1)(r=0.999 5),平均回收率为100.3%(RSD=1.5%,n=9)。结论本法简便,快速,准确,重现性好,适用于小儿氨酚烷胺颗粒的质量控制。OBJECTIVE To establish a HPLC-RID method for determination of paracetamol and amantadine hydrochloride in pediatric paracetamol and amantadine hydrochloride granules simultaneously. METHODS Waters Sun Fire C18（ 4.6 mm× 150 mm,5 μm） at 30 ℃ was used with methanol and water（ 10 ∶90,V/V） as the mobile phase,the flow rate was 1.5 mL·min^-1. RID was used as the detector and the temperature of detection cell was 30 ℃. RESULTS The calibration curves for paracetamol and amantadine hydrochloride were linear over the range of 0. 618 5-4. 948 0 mg·mL^-1（ r = 0.999 9）,0.253 2-2.025 6 mg·mL^-1（ r = 0.999 5）,respectively. The average recovery rates were 99.5%（ RSD = 1.8%,n = 9）,100.3%（ RSD = 1.5%,n = 9）,respectively. CONCLUSION This method is simple,rapid,accurate and reliable,which is suitable for the quality control of pediatric paracetamol and amantadine hydrochloride granules.

关 键 词：对乙酰氨基酚 小儿氨酚烷胺颗粒 高效液相色谱-示差折光检测法 

分 类 号：R927.2[医药卫生—药学]