HPLC法测定卡波姆类口腔黏附片中盐酸利多卡因的含量  

Determination of Lidocaine Hydrochloride in Buccal Adhesive Tablets Containing Carbomer by HPLC

作　　者：符旭东[1] 陈晨[1] 李银科[1] 王珊珊[2] 谢向阳[1] 

机构地区：[1]广州军区武汉总医院,武汉430070 [2]湖北中医药大学

出　　处：《中国药师》2015年第4期695-697,共3页China Pharmacist

基　　金：武汉市科技攻关计划(编号:201161038346)

摘　　要：目的：建立卡波姆类口腔黏附片中盐酸利多卡因的HPLC含量测定方法。方法：通过氯化钙沉淀供试品中的卡波姆,采用Welch C18色谱柱（250 mm×4.6 mm,5μm）,流动相为醋酸钠溶液（取冰醋酸50 ml,加水930 ml,用1 mol·L^-1氢氧化钠调p H至3.40）-乙腈（70∶30）;流速1.0 ml·min^-1,检测波长254 nm,柱温40℃,进样量20μl。结果：在0.10-2.00 mg·mL^-1的范围内,盐酸利多卡因的浓度与峰面积呈良好的线性关系（r=0.999 9）,平均回收率为100.2%,RSD为1.4%（n=9）。结论：本方法简单、准确、重复性好,可用于口腔黏附片中盐酸利多卡因的含量测定。Objective： To establish a method to determine the content of lidocaine hydrochloride in buccal adhesive tablets containing carbomer as an excipient by HPLC. Methods： Calcium chloride was used to precipitate carbomer in buccal adhesive tablets. The HPLC analysis was performed on a Welch C18column（ 250 mm × 4. 6 mm,5 μm） with the column temperature of 40℃. The mobile phase was the mixture of 0. 05% sodium acetate solution（ added 50 ml acetic acid into 930 ml distilled water,adjusting p H to 3. 40 with 1 ml·min^-1sodium hydroxide solution） and acetonitrile（ 70∶ 30）. The flow rate was 1. 0 ml·min^-1,the detection wavelength was at 254 nm and the injection volume was 20 μl. Results： Within the range of 0. 10-2. 00 mg·mL^-1,there was a good linear relationship between the concentration and the peak area of lidocaine hydrochloride（ r = 0. 999 9）. The average recovery was 100. 2%（ RSD = 1. 4%,n = 9）. Conclusion： The established method is simple,accurate and reproducible,which can be applied to determine the content of lidocaine hydrochloride in buccal adhesive tablets.

关 键 词：盐酸利多卡因 高效液相色谱法 卡波姆 口腔黏附片 

分 类 号：R927.2[医药卫生—药学]