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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 the simultaneous determination of theophylline, bromhexine hydrochloride and chlorphenamine maleate in the tea capsules. METHODS: ZORBAXExtend-C18 column (25 cm × 4.6 mm, 5 μm) was used. A solution of perchloric acid (70% ~ 72% mL, adjusted to pH 3.5 ± 0.02] (45:5:50) with triethylamine. The flow rate was 1.0 mL · min-1. The detection wavelength was 220 nm. The injection volume was 10 μL. The column temperature was 30 ℃. Results: Theophylline concentration was between 75.28 and 752.8 μg · mL-1, the concentration of bromhexine hydrochloride was between 16.12 and 161.2 μg · mL-1, the concentration of chlorpheniramine maleate between 1.488 and 14.88 μg · mL- 1 with the peak area showed a good linear relationship, r = 0.9993 ~ 1.000; theophylline, bromhexine hydrochloride, chlorpheniramine maleate low, medium and high concentration of the average recovery was 100.1% ~ 101.5%, 98.0 ~ 101.0% and 99.6% ~ 102.7%, respectively. The average recoveries were 100.7% (RSD = 0.72%), 99.4% (RSD = 1.5%) and 101.0% (RSD = 1.6%), respectively. Conclusion: This method is simple and accurate and can be used as quality control method of this preparation.