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高效液相色谱法测定茶新那敏片中盐酸溴己新含量
引用本文:陈乃江. 高效液相色谱法测定茶新那敏片中盐酸溴己新含量[J]. 中国药业, 2009, 18(8): 35-36
作者姓名:陈乃江
作者单位:江苏省连云港市药品检验所,江苏,连云港,222006
摘    要:目的建立测定茶新那敏片中盐酸溴己新含量的高效液相色谱(HPLC)法。方法色谱柱为Phenomenex C18柱(250inn×4.6mm,5μm),以用三乙胺调节pH至3.5的甲醇-0.2%磷酸溶液(65:35)为流动相,柱温为室温,流速为1.0mL/min,检测波长248nm。结果盐酸溴己新进样量在0.604~2.416μg范围内与峰面积线性关系良好,r=0.9999(n=5),平均回收率为99.45%,RSD为0.82%(n=6)。结论HPLC法简便、准确,可作为茶新那敏片质量控制方法。

关 键 词:高效液相色谱法  茶新那敏片  盐酸溴己新  含量测定

Content Determination of Bromhexine Hydrochloride In Aminophylline Bromhexine and Chlorphenamine Tablets by HPLC
Chen Naijiang. Content Determination of Bromhexine Hydrochloride In Aminophylline Bromhexine and Chlorphenamine Tablets by HPLC[J]. China Pharmaceuticals, 2009, 18(8): 35-36
Authors:Chen Naijiang
Affiliation:Chen Naijiang (Lianyungang Institute for Drug Control, Lianyungang, Jiangsu, China 222006)
Abstract:Objective To establish a HPLC method for the content determination of bromhexine hydroehloride in Aminophylline Bromhexine and Chlorphenamine Tablets. Methods The determination was performed on Phenomenex C18 column(250 mm ×4.6 mm,5 μm)with the mobile phase consisted of methanol-0. 2% phosphoric acid solution (65:35, pH was adjusted to 3.5 with triethylamine) at ambient temperature. The flow rate was 1.0 mL/min. The detection wavelength was 248 nm. Results The method showed a good linear relationship for bromhexine hydroehloride within the range of 0. 604 -2. 416 μg ( r =0. 9999, n =5). The mean recovery rate was 99.45% with RSD was 0. 82% ( n =6). Conclusion The method is simple, accurate. It can be used for quality control of Aminophylline Bromhexine and Chlorphenamine Tablets.
Keywords:HPLC  Aminophylline Bromhexine and Chlorphenamine Tablets  bromhexine hydrochloride  content determination
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