超高效液相色谱法同时测定复方氟嗪酸鼻喷剂中3种组分的含量

Simultaneous Determination of the Contents of 3 Components in Compound Ofloxacin Nasal Spray by UPLC

目的：同时测定复方氟嗪酸鼻喷剂中氧氟沙星、盐酸萘甲唑啉及马来酸氯苯那敏的含量。方法：采用超高效液相色谱法，色谱柱为WatersACQUITYUPLC BEHC18流动相为乙腈．1．03mol／L磷酸二氢铵溶液（含0．005mol／L的庚烷磺酸钠，pH=3．0）（30：70），流速为0．2ml／min，进样量为2μl；使用光电二极管阵列检测器，检测波长为220nin。结果：氧氟沙星、盐酸萘甲唑林、马来酸氯苯那敏检测质量浓度线性范围分别为29．76-208．3、2．153-15．068、4．064-28．45μg/ml（r≥0．9997），平均回收率分别为100．1％、100．3％、100．9％，RSD分别为1．25％、1．20％、O．99％（n=3）。结论：所建立的方法快速、准确，可用于复方氟嗪酸鼻喷剂的质量控制。

OBJECTIVE： To determine the contents of ofloxacin, naphazoline hydrochloride and chlorphenamine maleate in Compound ofloxacin nasal spray simultaneously. METHODS： UPLC method was established. The Waters ACQUITY UPLC BEH C18 column was used with mobile phase consisted of aeetonitrile-0.03 mol/L ammonium dihydrogen phosphate solution （containing 0.005 mol/L sodium heptanesulfonate, pH=3.0, 30：70） at the flow rate of 0.2 ml/min. The sample size was 2 ~1. Photodiode array detector was adopted, and the detection wavelength was set at 220 rim. RESULTS： The linear range were 29.76-208.3 μg/ml for ofloxacin, 2.153-15.068 μg/ml for naphazoline hydrochloride and 4.064-28.45 μg/ml for chlorphenamine maleate （r≥0.999 7）, re- spectively. The average recoveries were 100.1% （RSD=1.25%, n=3）, 100.3% （RSD=l.20%, n=3） and 100.9% （RSD= 0.99%, n=3）, respectively. CONCLUSIONS： The method is rapid and accurate, and can be used for quality control of Com- pound ofloxacin nasal spray.