HPLC梯度洗脱法同时测定鼻炎喷剂中3种组分的含量

Simultaneous Determination of 3 Components in Rhinitis Spray by HPLC with Gradient Elution

目的：建立同时测定鼻炎喷剂中盐酸麻黄碱、环丙沙星、醋酸泼尼松龙3种组分含量的方法。方法：采用高效液相色谱梯度洗脱法。色谱柱为SHIMADZU Shim-pack VP-ODS，流动相为甲醇．乙腈-0．05mol／L磷酸二氢钾（含0．25％三乙胺，pH3．0），流速为1．0ml／min，变换紫外检测波长分别为207、278、247nm，柱温为40℃。结果：盐酸麻黄碱、环丙沙星、醋酸泼尼松龙检测质量浓度线性范围分别为99．93～799．44、46．38-371．00、5．39-43．12gg／ml（n=0．9996～0．9998），平均回收率为100．4％（RSD=1．2％．n=3）、101．1％（RSD=1．3％，n=3）和101．0％（RSD=1．5％，n=3）。结论：建立的方法简便、灵敏、准确，可用于制订鼻炎喷剂的质量标准并为产品质量控制提供支持。

OBJECTIVE： To establish a method for simultaneous determination of ephedrine hydrochloride, ciprofloxacin and prednisolone acetate in Rhinitis spray. METHODS： HPLC with gradient elution method was adopted. The determination was performed on SHIMADZU Shim-pack VP-ODS column with mobile phase consisted of methanol-acetonitrile-0.05 mol/L potassium dihydrogen phosphate （containing 0.25% triethylamine, pH 3.0） at the flow rate of 1.0 ml/min. The detection wavelength was set at 207 nm, 278 nm and 247 nm and column temperature was 40 ℃. RESULTS： The linear ranges were 99.93-799.44 μg/ml for ephed- rine hydrochloride, 46.38-371.00 μg/ml for ciprofloxacin and 5.39-43.12 μg/ml for prednisolone acetate （r=0.999 6-0.999 8）; their average recoveries were 100.4% （RSD=1.2%, n=3）, 101.1% （RSD=1.3% ,n=3） and 101.0% （RSD=1.5%, n=3）. CONCLUSIONS ： The method is simple, sensitive, accurate, and can be used for the formulation of quality standard and quality control of Rhinitis spray.