HPLC法测定盐酸羟甲唑啉滴鼻液中 苯扎溴铵的含量

HPLC法测定盐酸羟甲唑啉滴鼻液中苯扎溴铵的含量

赵晓頔,张肖宁,杨利红

黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所,黑龙江省食品药品检验检测所

收稿日期:2016-04-14 修回日期:2016-05-03 出版日期:2016-06-25 发布日期:2016-06-25

Determination of Benzalkonium Bromide in Oxymetazoline Hydrochloride Nasal Drops by HPLC

HEILONGJIANG PROVINCE FOOD AND DRUG INSPECTIONG,,

Received:2016-04-14 Revised:2016-05-03 Online:2016-06-25 Published:2016-06-25

摘要/Abstract

摘要： ［摘要］目的：建立测定盐酸羟甲唑啉滴鼻液中苯扎溴铵含量的高效液相色谱（HPLC）法。方法：采用 Waters XBridgeTM Shield RP18 柱（4.6 mm?250 mm，5 μm），流动相为0.005 mol?L-1醋酸铵溶液（每1000 mL中含三乙胺10 mL，用冰醋酸调pH至5.0）-乙腈（40∶60），流速为1.0 mL?min-1，检测波长214 nm，柱温25 ℃，进样量20 μL。结果；盐酸羟甲唑啉滴鼻液中苯扎溴铵浓度在0.0109～0.327 mg?mL-1（r=0.9995，n=6）范围内线性关系良好，平均回收率为100.1%，RSD为1.0%(n=9)。结论：本方法简便准确，重复性好，可作为盐酸羟甲唑啉滴鼻液中苯扎溴铵的含量测定方法。

Abstract: [Abstract]Objective： To establish a high performance liquid chromatography（HPLC） for determining the content of benzalkonium bromide in oxymetazoline hydrochloride nasal drops. Methods：A Waters XBridgeTM Shield RP18 column（4.6 mm×250 mm，5μm） was used with a mobile phase of 0.005 mol·L-1 ammonium acetate solution (consisting of 10 mL triethylamine per 1000 mL，adjusted to pH5.0 by glacial acetic acid)-acetonitrile(40：60) at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 214 nm， and the column temperature was 25 (C. Results：The concentration of benzalkonium bromide in the range of 0.0109~0.327 mg·mL-1 showed good liner relation with the peak area (r=0.9995， n=6). The average recovery was 100.1%，RSD=1.0%，(n=9). Conclusions： The method can be used for the content determination of benzalkonium bromide in Oxymetazoline Hydrochloride Nasal Drops which provides the advantage of simplicity， accuraty and repeatability.

赵晓頔,张肖宁,杨利红. HPLC法测定盐酸羟甲唑啉滴鼻液中苯扎溴铵的含量[J]. .