高效液相色谱法测定复方盐酸萘甲唑啉鼻用喷剂中盐酸萘甲唑啉和地塞米松磷酸钠的含量

目的建立高效液相色谱法（HPLC）测定复方盐酸萘甲唑啉鼻用喷剂中盐酸萘甲唑啉和地塞米松磷酸钠的含量。方法采用HPLC法，色谱柱为Diamonsil C18柱，室温为25℃，以甲醇：水：三乙胺：磷酸（53：47：0．25：0．075）为流动相，流速0．85ml/min；检测波长242nm；进样量为20μl；外标法定量。结果盐酸萘甲唑啉在10．2～204．0mg/L范围内呈良好线性关系（r=0．9996）；回收率为100．5％，相对标准偏差（RSD）=1．059％；地塞米松磷酸钠在3．94～78．72mg/L范围内呈良好线性关系（r=0．9995），回收率为101．0％，RSD：1．259％。结论本方法操作简便，结果准确，灵敏可靠，重复性好，可用于复方盐酸萘甲唑啉鼻用喷剂的含量测定。

Detection of the levels of naphazoline hydrochloride and dexamethasone sodium phosphate in compound naphazoline hydrochloride nasal drops by HPLC

Objective To establish an HPLC method to detect the levels of naphazoline hydrochloride and dexamethasone so dium phosphate in compound naphazoline hydrochloride nasal drops. Methods Detection was conducted on a Cl8 column at a room temperature of 25℃. The mobile phase consisted of methanol-water-triethyamine-phosphoric acid （53： 47： 0.25： O. 075 ） with a flow rate of 0.85 ml/min. Detection wavelength was set at 242 nm and the sample feed size was 20 μl. Results Naphazoline hydrochloride at the ran- ges of 10.2 - 204 mg/L displayed good linearity （r = 0.9996）. Average recovery rate of naphazoline hydrochloride was 100.5% and rela- tive standard deviation （RSD） was 1. 059%. Dexamethasone sodium phosphate at the ranges of 3.94 -78.72 mg/L also displayed good linearity （r = 0.9995）. Average recovery rate of dexamethasone sodium phosphate was 101.0%, and RSD was 1. 259%. Conclusion This method seemed to have the following features： simple operation, accurate resuhs, high sensitivity, good reliability, and good repeat ability, and it could be used for the detection of the levels of the substances in the compound naphazoline hydrochloride nasal drops.