摘要
目的:建立高效液相色谱法同时测定盐酸普鲁卡因注射液中盐酸普鲁卡因含量及杂质对氨基苯甲酸的限量。方法:采用 hypersil C_(18)色谱柱(4.6 mm×250 mm,5μm);以缓冲液[0.05 mol·L^(-1)磷酸二氢钾-0.0025 mol·L^(-1)庚烷磺酸钠(1:1,用磷酸调节 pH 至3.0)]-乙腈(90:10)为流动相;检测波长为283 nm;柱温40℃;流速1 mL·min^(-1),同时应用对氨基苯甲酸与盐酸普鲁卡因含量比为1.2%时的峰面积比值作为对氨基苯甲酸检查限量值。结果:盐酸普鲁卡因及对氨基苯甲酸线性范围分别为0.0125～0.125 mg·mL^(-1)(r=0.9998)和0.2～2μg·mL^(-1)(r=0.9999),平均回收率分别为102.3%,102.5%;对氨基苯甲酸杂质限量值为1.865%。结论:本测定方法简便、快速,结果准确,可用于同时测定盐酸普鲁卡因注射液中盐酸普鲁卡因含量及对氨基苯甲酸杂质限量。
Objective：To develop an HPLC method for determination of content of procaine hydrochloride （PCHC） and its decomposed product p - amino benzoic acid （PABA） in procaine hydrochloride injection. Methods：The HPLC was performed on a hypersil Cas column （4.6mm×250mm,5μm） ,the mobile phase was buffer solution [ 0. 05 mol· L^-1 potassium dihydrogen phosphate -0. 0025 mol· L^-1 sodium 1 -heptanc sulfonic acid （1： 1, adjusted to pH 3.0 with phosphoric acid） ] - acetontrile （90： 10） ,the detection wavelength was 283 nm,the flow rate 1.0 mL·min^- 1 and the column temperature 40 ℃. Meanwhile, the area rate of PABA to PCHC at their content rate 1.2% was considered as the PABA limit. Results：The PCHC and the PABA linear range were0. 0125 -0. 125 mg·mL^ - 1 （ r = 0. 9998 ） and 0. 2 - 2 μg ·mL^- 1 （ r = 0. 9999 ） respectively, and the average recoveries were 102.3% and 102.5%. The area rate of PABA to PCHC is below 1. 865%. Conclusions：The method is convenient,rapid and accurate,which can be used to assay PCHC and PABA in procaine hydrochloride injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第8期1249-1251,共3页
Chinese Journal of Pharmaceutical Analysis
作者简介
魏世超,Tel：（027）83624090；E-mail：weik66@sina．com
