摘要
目的:建立反相HPLC法测定注射用盐酸丁卡因含量、含量均匀度及有关物质。方法:采用Agela Venusil XBP C18(L)(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水(含0.4%三乙胺,用稀磷酸调节pH至3.0)(55∶45)为流动相,流速:1.0 mL·min-1,检测波长:315 nm(含量及含量均匀度测定波长),308 nm(有关物质测定波长);柱温:35℃,进样体积:20μL。结果:盐酸丁卡因在0.2064～41.28μg·mL-1浓度范围内呈良好线性关系(r=0.9999)(315 nm和308 nm);平均回收率(n=9)为101.3%;杂质a在0.0214～2.14μg·mL-1范围内呈良好线性关系(r=0.9996)(308 nm);平均回收率(n=9)为101.4%。结论:本法简便、准确,重复性好,专属性强,灵敏度高,可用于注射用盐酸丁卡因的含量、含量均匀度测定和有关物质检查。
Objective ： To develop an RP - HPLC for the determination of content, content uniformity and its related substances in tetracaine hydrochloride for injection. Methods：An Agela Venusil XBP C18 （L） （4.6 mm x 250 mm, 5 p,m）column was adopted with a mobile phase of methanolwater（55： 45, containing 0. 4% triethylamine, adjusted to pH 3.0 with dilute phosphoric acid）. The flow rate was 1.0 mL . min- 1 ;the detection wavelength for content and content uniformity determination of tetracaine hydrochloride was 315 nm, and the wavelength for the related substance determination was 308 nm. The column temperature was 35 ℃, and the volume of injection was 20 μL. Results：A good linear correlation of tetracaine hydrochloride was observed within the range of 0. 2064 -41. 28μg . mL-1 （r =0. 9999） （315 nm and 308 nm）. The average recovery was 101.3% with RSD 1.0% （n =9）. The cali- bration curves of impurity a were 0. 0214 -2. 14 μg . mL-l（ r = 0. 9996） （308 nm）. The average recovery was 101.4% with RSD 0. 5% （n = 9 ）. Conclusion ：The method is simple, accurate and repeatable, with strong selectivi- ty and high sensitivity. It can be applied to the determination of content, content uniformity and its related sub- stances in tetracaine hydrochloride for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第10期1877-1881,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
反相高效液相色谱
注射剂
盐酸丁卡因
含量均匀度
有关物质
局麻药推选改进
RP - HPLC
injection
tetracaine hydrochloride
content uniformity
related substances
local anaesthet-ics standard improvinent
