高效液相色谱法测定复方酚咖伪麻胶囊的含量均匀度

Determination of content uniformity of compound paracetamol caffeine and pseudoephedrine hydrochloride capsules by high-performance liquid chromatography

目的:建立HPLC法测定复方酚咖伪麻胶囊中盐酸伪麻黄碱、咖啡因、盐酸氯哌丁和马来酸氯苯那敏的含量均匀度。方法:色谱柱为XTerra C18(250 mm×4.6 mm,5μm),流动相为甲醇-磷酸盐溶液(0.02 mol/L磷酸二氢钾溶液,1 000 mL中加入0.2 mL三乙胺),梯度程序洗脱,流速1.0 mL/min,检测波长215 nm。结果:盐酸伪麻黄碱、咖啡因、盐酸氯哌丁和马来酸氯苯那敏质量浓度分别在15.07~150.75、12.50~125.00、6.12~61.20和1.25~12.54μg/mL范围内呈良好线性关系(r≥0.999 8);平均回收率(n=6)分别为99.8%,100.0%,100.2%和100.7%。结论:该法简单、快速、准确,适用于复方酚咖伪麻胶囊含量均匀度测定。

Objective: To establish a high-performance liquid chromatography method for determination of the content uniformity of pseudoephedrine hydrochloride, caffeine, cloperastine hydrochloride, and chlorphenamine maleate in compound paracetamol caffeine and pseudoephedrine hydrochloride capsules. Methods: The XTerra C18 column(250 mm × 4.6 mm, 5 μm) was used with a mobile phase of methanol-phosphate solution(1 000 mL of 0.02 mol/Lpotassium dihydrogen phosphate solution containing 0.2 mL of triethylamine);after a gradient elution at a flow rate of 1.0 mL/min, the detection was performed at a wavelength of 215 nm. Results: The quality versus concentration curves showed good linearity for pseudoephedrine hydrochloride, caffeine, cloperastine hydrochloride, and chlorphenamine maleate over the range of 15.07 ~ 150.75, 12.50 ~ 125.00, 6.12 ~ 61.20, and 1.25 ~ 12.54 μg/mL, respectively(r ≥ 0.999 8), with their respective mean recovery rates(n = 6) as 99.8%, 100.0%, 100.2%, and 100.7%.Conclusion: The established method is simple, rapid, and accurate, making it applicable for determination of the content uniformity of compound paracetamol caffeine and pseudoephedrine hydrochloride capsules.