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目的建立HPLC法测定鼻腔洗液中盐酸溴乙新和氢化可的松的含量。方法采用Kromasil C18(5μm,4.6×250mm)色谱柱;流动相为水(含0.025mmol·L-1KH2PO4、0.1%三乙胺、0.3%磷酸):乙腈(60:40);检测波长249nm;流速为1.0ml·min-1;进样量20μl。结果盐酸溴乙新和氢化可的松的线性范围分别为1.6~12.8μg/ml(r=0.9996),5~40μg/ml(r=0.9999);平均加样回收率分别为:99.2%(RSD=0.5%),99.4%(RSD=0.4%,n=6);日内RSD分别为0.5%和0.6%(n=5),日间RSD分别小于0.7%和0.6%(n=3)。结论该方法简便、准确,适合该制剂质量检验分析。
OBJECTIVE To establish a HPLC method for the determination of bromine and hydrocortisone in nasal cavity lotion. Methods The mobile phase was water (containing 0.025 mmol·L-1 KH2PO4, 0.1% triethylamine and 0.3% phosphoric acid): acetonitrile (60:40). The detection wavelength was 249 nm. The flow rate 1.0ml · min-1; injection volume 20μl. Results The linear range of Bromide and Hydrocortisone were 1.6-12.8μg / ml (r = 0.9996) and 5-40μg / ml (r = 0.9999), respectively. The average recoveries were 99.2% (RSD (RSD = 0.4%, n = 6). Intra-day RSD was 0.5% and 0.6% respectively (n = 5). Daytime RSD was less than 0.7% and 0.6% (n = 3), respectively. Conclusion The method is simple and accurate, suitable for the quality inspection and analysis of the preparation.