摘要
目的:建立HPLC法同时测定茶新那敏薄膜包衣片中茶碱、盐酸溴己新和马来酸氯苯那敏的含量。方法:采用ZORBAXExtend-C18(25 cm×4.6 mm,5μm)色谱柱;以甲醇-乙腈-0.017 mol·L-1高氯酸液[取高氯酸(70%~72%)2.4 mL,加水1000 mL,用三乙胺调节pH至3.5±0.02](45∶5∶50)为流动相;流速1.0 mL·min-1;检测波长220 nm;进样量为10μL;柱温:30℃。结果:茶碱浓度在75.28~752.8μg·mL-1之间、盐酸溴己新浓度在16.12~161.2μg·mL-1之间、马来酸氯苯那敏浓度在1.488~14.88μg·mL-1之间均与峰面积呈良好线性关系,r=0.9993~1.000;茶碱、盐酸溴己新、马来酸氯苯那敏低、中、高3个浓度平均加样回收率分别为100.1%~101.5%,98.0~101.0%,99.6%~102.7%;平均回收率分别为100.7%(RSD=0.72%),99.4%(RSD=1.5%),101.0%(RSD=1.6%)。结论:本法操作简便,结果准确,可作为该制剂的质量控制方法。
Objective:To establish an HPLC method for simultaneous determination of theophylline,bromhexine hydrochloride and chlorphenamine maleate in aminophylline bromhexine and chlorphenamine membrane coat tablets.Methods:The HPLC method was performed in the following modules.The sample was separated and analyzed on ZORBAX Extend-C18(25 cm×4.6 mm,5 μm)column,and methanol-acetonitrile-0.017 mol·L-1 perchloric acid solution [to 2.4 mL of perchloric acid(70%-72%),add 1000 mL of water,adjusted pH to 3.5±0.02 with triethylamine](45∶ 5∶ 50) was used as mobile phase.The flow rate was at 1.0 mL·min-1,the detective wavelength was at 220 nm,the injection volume was 10 μL,and the column temperature was 30 ℃.Results:The theophylline,bromhexine hydrochloride and chlorphenamine maleate peaks in the sample chromatogram were completely separated from other ingredient peaks.The calibration curve was linear at a range of 75.28-752.8 μg·mL-1for theophylline with r=0.9993,of 16.12-161.2 μg·mL-1 for bromhexine hydrochloride with r=1.000 and of 1.488-14.88 μg·mL-1 for chlorphenamine membrane with r=0.9993.The average recoveries(n=3) of theophylline samples at low,moderate and high concentrations were between 100.1%-101.5% with an average recovery of 100.7%(RSD=0.72%);of bromhexine hydrochloride were between 98.0%-101.0%,with an average recovery of 99.4%(RSD=1.5%);of chlorphenamine maleate were between 99.6%-102.7%,with an average recovery of 101.0%(RSD=1.6%).Conclusion:This method is simple and accurate,which can be used for quality control of this preparation.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第10期1861-1865,共5页
Chinese Journal of Pharmaceutical Analysis
基金
浙江省嘉兴市科技局资金资助项目(2010AY1064)
关键词
茶新那敏薄膜包衣片
茶碱
盐酸溴己新
马来酸氯苯那敏
HPLC
质量控制
aminophylline bromhexine and chlorphenamine membrane coat tablets
theophyllin
bromhexine hydrochloride
chlorphenamine maleate
HPLC
quality control