HPLC法同时测定茶新那敏薄膜包衣片中三组分的含量

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ZORBAX Extend-C₁₈(25 cm×4.6 mm,5 μm)色谱柱;以甲醇-乙腈-0.017 mol·L^-1高氯酸液 (45∶5∶50)为流动相;流速1.0 mL·min^-1;检测波长220 nm;进样量为10 μL;柱温:30 ℃。 结果: 茶碱浓度在75.28~752.8 μg·mL^-1之间、盐酸溴己新浓度在16.12~161.2 μg·mL^-1之间、马来酸氯苯那敏浓度在1.488~14.88 μg·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 (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.