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目的:建立高效液相色谱法测定复方氨酚苯海拉明片中盐酸麻黄碱和盐酸苯海拉明的含量及均匀度。方法:采用DiamonsilTMC18柱(4.6mm×250mm,5μm),以[甲醇-水-冰醋酸-四氢呋喃-十二烷基硫酸钠(25∶35∶0.5∶2∶0.35g)]-乙腈(68∶32)为流动相;检测波长为257nm。结果:盐酸麻黄碱平均回收率为99.1%,RSD为0.7%(n=5),线性范围为1.578~12.624μg;盐酸苯海拉明平均回收率为99.0%,RSD为0.7%(n=5),线性范围为1.53~12.24μg。结论:该方法重复性好,结果准确,可用于该制剂的质量控制。
OBJECTIVE: To establish a method for the determination of content and uniformity of ephedrine hydrochloride and diphenhydramine hydrochloride in compound paracetamol and diphenhydramine hydrochloride tablets by high performance liquid chromatography. METHODS: Diamonsil TMC18 column (4.6 mm × 250 mm, 5 μm) was used to elute with [methanol-water-glacial acetic acid-tetrahydrofuran- sodium dodecylsulfate (25:35:0.5:2:0.35 g) ) As the mobile phase; detection wavelength of 257nm. Results: The average recoveries of ephedrine hydrochloride were 99.1%, RSD was 0.7% (n = 5), and the linear range was 1.578 ~ 12.624μg. The average recovery of diphenhydramine hydrochloride was 99.0% and the RSD was 0.7% (n = 5 ), The linear range of 1.53 ~ 12.24μg. Conclusion: The method has good repeatability and accurate results and can be used for the quality control of the preparation.