离子对HPLC测定萘敏维滴眼液的含量并检查有关物质

Determination of the contents and related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitam in B_(12) eye drops by ion-pair HPLC

目的建立测定萘敏维滴眼液中盐酸萘甲唑林和马来酸氯苯那敏含量及检查有关物质的方法。方法采用离子对HPLC法，色谱柱为Luna C18色谱柱，乙腈-1．0％十二烷基硫酸钠-冰醋酸（57：43：0．3，稀硫酸调pH3．4）为流动相，检测波长为280nm。结果盐酸萘甲唑林的线性范围为5．0～17．5μg·ml^-1（r=0．9997），高、中、低浓度的平均回收率为99．42％-100．5％，RSD为0．35％～0．81％；马来酸氯苯那敏的线性范围为50．0～175．0μg·ml^-1（r=0．9995），高、中、低浓度的平均回收率为99．59％～100．8％，RSD为0．33％-0．52％。3批样品中有关物质的含量分别0．82％、0．84％、0．85％。结论所用方法准确、简便、快速，适用于萘敏维滴眼液的质量控制。

OBJECTIVE To establish a method for determination of the contents and related substances in Naphazoline hydrochloride（ NH）, Chlorphenamine maleate（CM） and Vitamin B12 eye drops. METHODS Ion- pair RP- HPLC method was adopted. Luna C18 column （ 150 mm×4.6 mm,5 μm） was used with UV detection at 280 nm, and the mobile phase consisted of acetonitrile - 1.0% sodium dodecyl sulfate - glacial acetic acid （57 ： 43 ： 0. 3, adjusted pH to 3.4 with dilute sulphuric acid）. RESULTS The calibration curve was linear（r =0. 9997） within the range of 5.0 to 17.5 μg·ml^-1 for Naphazoline hydrochloride. The average recovery was from 99. 42% to 100. 5% for three different levels of the amount of Naphazoline hydrochlofide,the RSD was from 0. 35% to 0. 81%. The calibration curve was linear（r =0. 9995） within the range of 50. 0 to 175.0 μg·ml^-1 for chlorphenamine maleate. The average recovery was from 99. 59% to 100. 8% for three different levels of the amount of chlorphenamine maleate, the RSD was from 0. 33% to 0. 52%. The contents of related substance was 0. 82% ,0. 84% and 0. 85% , respectively in three batches of samples. CONCLUSION This method is simple, quick, accurate and effective for testing related substances in the eye drops and for content determination. This method is suitable for quality control of Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B12 eye drops.