高毓涛,李娜,李亚男.HPLC-RID法同时测定复方氨酚烷胺片中对乙酰氨基酚和盐酸金刚烷胺的含量[J].中国药品标准,2017,18(3):181-185 |
HPLC-RID法同时测定复方氨酚烷胺片中对乙酰氨基酚和盐酸金刚烷胺的含量 |
Determination of Contents of Compound Paracetamol and Amantadine Hydrochloride Tablets by Using HPLC-RID MethodGao Yutao1,Li Na2,LiYanan1(1. Dandong City Drug Inspection Test Center, Dandong 118002; 2.LiaoningSludanSPharmaceuticalSCo.,Ltd., Dandong 118002) |
投稿时间:2017-03-28 修订日期:2017-06-06 |
DOI: |
中文关键词: HPLC-RID法 对乙酰氨基酚 盐酸金刚烷胺 复方氨酚烷胺片 含量测定 |
英文关键词: HPLC-RID Amantadine Hydrochloride Paracetamol Compound paracetamol and Amantadine Hydrochloride Content determination |
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中文摘要: |
目的:建立同时测定复方氨酚烷胺片中对乙酰氨基酚和盐酸金刚烷胺含量的HPLC-RID法。方法:采用Waters SunFire C18色谱柱(4.6 mm×150 mm,5 μm),流动相为甲醇-水(10:90),柱温为30 ℃,进样量为20 μl,流速为1.5 ml﹒min-1,检测器为RID,检测池温度为30 ℃。结果:在选定的色谱条件下,对乙酰氨基酚在0.6292~5.0332 mg﹒ml-1的浓度范围内与其峰面积呈良好的线性关系(r=0.999 6),平均回收率为100.1﹪,其RSD=1.4﹪(n=9),盐酸金刚烷胺在0.2522~2.0176 mg﹒ml-1的浓度范围内与其峰面积呈良好的线性关系(r=0.999 4),平均回收率为100.4﹪,其RSD=1.5﹪(n=9)。结论:本法简便,快速,准确,重现性好,适用于复方氨酚烷胺片中对乙酰氨基酚和盐酸金刚烷胺的质量控制。 |
英文摘要: |
Objective:To establish a HPLC-RID method for determination of paracetamol and amantadine hydrochloride in compoundparacetamolSandSamantadineShydrochloride tablets simultaneously. Methods: Waters SunFire C18 (4.6 mm× 150 mm, 5 μm) column was used with methanol and water (10: 90) as the mobile phase, the column was 30 ℃, the flow rate was 1.5 ml.min-1. RID was used as the detector and the temperature of detection cell was 30℃. Results: Under selected chromatographic conditions, Acetaminophen in the 0.6292 ~ 5.0332 mg﹒ml-1 had a good linear relationship with its peak area (r=0.9996), The average recovery rates were 100.1﹪, RSD=1.4﹪, (n=9), Amantadine Hydrochloride in 0.2522~2.0176 mg﹒ml-1 had a good linear relationship with its peak area (r=0.999 4) , The average recovery rates were 100.4﹪, RSD=1.5﹪, (n=9).Conclusion:This method is simple, rapid, accurate and reliable, which is suitable for the quality control of compound paracetamol and amantadine hydrochloride tablets. |
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