摘要
目的 建立同时测定复方盐酸萘甲唑啉滴眼液中盐酸萘甲唑啉（NPH）和盐酸苯海拉明（DPH）含量的方法。方法 采用高效液相色谱法。以Agilent CN柱（250 mm×4.6 mm,5μm）为色谱柱;乙腈-水-三乙胺（50∶50∶0.5）（用冰醋酸调节p H值至6.5）为流动相;流速为1.0 m L/min;紫外检测波长为258 nm。结果 NPH和DPH的流出时间分别为6.6 min和9.7 min,线性范围分别为3.12-18.75μg/m L（r=0.999 9）、12.50-75.00μg/m L（r=0.999 9）,平均回收率分别为99.97%（RSD=0.62%,n=9）、100.07%（RSD=0.58%,n=9）。结论 该方法简单灵敏,准确和选择性好,可用于复方盐酸萘甲唑啉滴眼液的质量控制。
Objective To establish a method for simultaneous content determination of naphazoline hydrochloride （NPH） and diphenhydramine hydrochloride （DPH） in compound naphazoline hydrochloride eye drops. Methods HPLC was adopted. The determination was performed on Agilent CN （250 mm × 4. 6 mm, 5 μm） with mobile phase consisted of acetonitrile-water-triethylamine （50：50：0.5） （pH 6.5, adjusted by glacial acetic acid） at the flow rate of 1.0 mL/min. The UV detection wavelength was set at 258 nm. Results The retention times for NPH and DPH were 6.6 min and 9.7 min, respectively. The calibration curves were linear in the range of 3.12-18.75 μg/mL （r=0.999 9） for NPH, and 12.50-75.00 μg/mL （r=0.999 9） for DPH. The average recoveries for NPH and DPH were 99.97% （RSD=0.62%, n=9）, 100.07% （RSD=0.58%, n=9）, respectively. Conclusion This method is simple, selective, accurate and suitable for the quality control of compound naphazoline hydroehloride eye drops.
出处
《今日药学》
CAS
2014年第11期791-793,共3页
Pharmacy Today
关键词
复方盐酸萘甲唑啉滴眼液
高效液相色谱法
盐酸萘甲唑啉
盐酸苯海拉明
含量测定
compound naphazoline hydrochloride eye drops
HPLC
naphazoline hydrochloride
diphenhydraminehydrochloride
content determintation
