RP-HPLC法测定马来酸非尼拉敏盐酸萘甲唑啉滴眼液中马来酸非尼拉敏的含量

目的建立测定马来酸非尼拉敏盐酸萘甲唑啉滴眼液中马来酸非尼拉敏含量的RP-HPLC法。方法采用Agilent C₁₈（150 mm×4.6mm,5μm）色谱柱,流动相:V[乙酸缓冲液(0.1 mol·L^-1乙酸铵,0.5%三乙胺,乙酸调pH至4.0)]:V（甲醇）=97:3,柱温20℃,流速1 mL·min^-1,检测波长262 nm。外标法计算含量。结果在该色谱条件下,马来酸非尼拉敏线性良好（r>0.999,n=7）,加样回收率为97%～103%（n=3）,RSD<2.0%（n=3）。样品在24 h内稳定。测得样品含量合格,为97%～103%。结论本方法简便快速,所测结果准确可靠,重复性好。

Determination of pheniramine maleate in pheniramine maleate naphazoline hy- drochloride eye drops by reverse-phase high performance liquid chromatography

A/M To develop a reverse-phase high performance liquid chromatography （RP-HPLC） to determine pheniramine maleate concentration in the pheniramine maleate naphazoline hydrochloride eye drops. METHODS The HPLC separation was carried out on an Agilent Cls（ 150 mm x 4.6 mm,5 um） column, using a UV detector with 262 ran wavelength. The mobile phase was 0.1 mol· L- l ammonium acetate buffer （0.5 % triethlamine, adjusted to pH 4.0 with acetic acid）-methanol solution = 97：3（V/V）, with velocity of 1 mL＇min-1 and column temperature of 20~C. RESULTS The good linearity of pheniramine maleate under chromatography was found （ r 〉 O. 999, n = 7）. The recovery values were between 97% and 103% （ n = 3）. The RSD values were below 2.0% （ n = 3）. The sample was stable in 24 h. The samples reached standardized qualification. CONCLUSION RP-tWLC is proved to be simple, swift, accurate and reliable and has good reproducibility.