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目的:建立同时测定扑麻滴鼻液中盐酸麻黄碱和马来酸氯苯那敏含量的HPLC方法。方法:采用:PurospherSTAR RP18色谱柱(150 mm×4.6 mm,5μm),以磷酸盐缓冲液(p H 3.0±0.1)-乙腈(82∶18)为流动相,流速为1.0 ml·min-1,在210nm波长处同时检测盐酸麻黄碱和马来酸氯苯那敏,柱温35℃,进样量20μl。结果:盐酸麻黄碱和马来酸氯苯那敏分别在19.81~118.85μg·ml-1和6.21~37.25μg·ml-1浓度范围内线性关系良好,r分别为0.999 6和0.999 8。平均回收率分别为100.39%(RSD=0.69%,n=9)和100.11%(RSD=0.60%,n=9)。结论:该方法快速简便、重复性、准确性好,可用于该制剂中盐酸麻黄碱和马来酸氯苯那敏的含量测定。
OBJECTIVE: To establish an HPLC method for the simultaneous determination of chlorphenamine hydrochloride and chlorphenamine maleate in plutolane nasal drops. METHODS: Purospher STAR RP18 column (150 mm × 4.6 mm, 5 μm) with phosphate buffer (p H 3.0 ± 0.1) -acetonitrile (82:18) as mobile phase at a flow rate of 1.0 ml · min- 1, simultaneous detection of ephedrine hydrochloride and chlorpheniramine maleate at 210nm wavelength, column temperature 35 ℃, injection volume 20μl. RESULTS: Ephedrine hydrochloride and chlorphenamine maleate showed good linearity in the range of 19.81-118.85μg · ml-1 and 6.21-37.25μg · ml-1, respectively, with r of 0.999 6 and 0.999 8, respectively. The average recoveries were 100.39% (RSD = 0.69%, n = 9) and 100.11% (RSD = 0.60%, n = 9), respectively. Conclusion: The method is rapid, simple, reproducible and accurate. It can be used for the determination of ephedrine hydrochloride and chlorphenamine maleate.