HPLC法测定复方萘甲唑林滴眼液中盐酸萘甲唑林和马来酸氯苯那敏的含量

目的建立HPLC测定复方萘甲唑啉滴眼液中盐酸萘甲唑啉和马来酸氯苯那敏含量的检测方法。方法采用反相液相色谱和紫外检测，色谱柱为美国迪马公司（钻石）Diamonsil C18（250mm×4．6mm，5μm）；流动相是O．05mol·L^-1磷酸二氢钾（2％三乙胺，磷酸液调pH至5．0）：甲醇：水（V：V：V=20：60：20），流速为0．8mL·min^-1，进样量：5μL，柱温：40℃，柱压75bar，检测波长入=225am。结果盐酸萘甲唑啉和马来酸氯苯那敏的流出时间分别为4．758min和7．364min，线性范围分别是6．02—72．24μg·mL^-1、6．08～72．96μg·mL^-1；平均回收率分别为97．56％、97．24％；RSD分别为0．37％、0．69％（n=9）。结论本法简便，准确和选择性好，可用于复方萘甲唑啉滴眼液的质量控制。

Determination of Naphazoline Hydrochloride and Chlorphenamine Mal- eateide in Naphazoline Completion eye drops by HPLC

OBJECTIVE To develop an HPLC assay for the determination of naphazoline hydrochloride （NPH） and Chlorphenamine Maleateide （CPM） in Naphazoline Compound eye drops. METHODS The RP-HPLC and UV detection was used with column for Diamonsil C18 （250mm × 4. 6mm, 5μm）. The mobile phase consisted of 20% 0. 05 tool. L^- 1 Potassium dihydrogen phosphate （20% Triethylamine, pH 5.0, adjusted by phosphate solution） ,60% methanol and 20% water. The flow rate was 0. 8mL .min^-1 with injection volume 5μL Column temperature 40℃, Column pressure 75bar,Detection wavelength h =225 nm. RESULTS The retention times for NPH and CPM were 4. 758 and 7. 364min, respectively. The calibration eurveswere linear in the range of 6. 02 - 72. 24μg . mL^-1 for NPH and 6. 08 -72. 96μg . mL^-1 for CPM. The average recoveries for NPH and CPM were 97.50% （RSD 0. 37% ） and 97. 24% （RSD 0. 69% ） ,respectively. CONCLUSION This simple,accurate and selective method is suitable for the quality control of Naphazoline Compound eye drops.