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目的:建立测定盐酸氮卓斯汀鼻喷剂中盐酸氮卓斯汀含量的高效液相色谱方法。方法:色谱柱:Diamonsil C_(18)柱(250 mm×4.6 mm,5μm);流动相:4%三乙胺(用醋酸调节pH至6.0)-乙腈-甲醇(45:21:34);检测波长:289 nm;流速:1.0ml·min~(-1);柱温:30℃。结果:盐酸氮卓斯汀在80~800μg·ml~(-1)范围内呈良好的线性关系(r=1.000 0),平均加样回收率为99.93%,RSD=0.82%(n=9)。结论:本方法操作简便,灵敏,结果准确可靠,可用于盐酸氮卓斯汀鼻喷剂的质量控制。
Objective: To establish a high performance liquid chromatographic method for the determination of azelastine hydrochloride in azelastine hydrochloride nasal spray. METHODS: Diamonsil C_ (18) column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 4% triethylamine (adjusted to pH 6.0 with acetic acid) Wavelength: 289 nm; flow rate: 1.0 ml · min -1; column temperature: 30 ° C. Results: Azelastine hydrochloride showed a good linearity (r = 1.000 0) in the range of 80-800 μg · ml -1 with an average recovery of 99.93% and a RSD of 0.82% (n = 9) . Conclusion: The method is simple, sensitive and accurate. It can be used for the quality control of azelastine hydrochloride nasal spray.