摘要
目的研究浓盐酸普鲁卡因注射液含量及杂质对氨基苯甲酸的测定方法。方法采用Grace Smart C_(18)色谱柱(250mm×4.6 mm,5μm)和Agilent Technologies C_(18)色谱柱(250 mm×4.6 mm,5μm);以含0.1%庚烷磺酸钠的0.05mol·L^(-1)磷酸二氢溶液钾溶液(用磷酸调节pH值至3.0)-甲醇(68∶32)为流动相;检测波长:279nm(杂质对氨基苯甲酸检测),290nm(普鲁卡因含量测定);流速:1 ml·min^(-1),进样量:10μl。结果经方法学验证,对氨基苯甲酸在0.1~9.6μg·ml^(-1)范围内有良好的线性关系,回收率为99.6%,RSD为1.9%;浓盐酸普鲁卡因注射液浓度在4.00~40.01μg·ml^(-1)范围内线性关系良好,回收率为101.5%,RSD为1.5%。结论建立的测定方法可行。
Objective To establish a method for determination of concentrated procaine hydrochloride injection and para-amino benzoic acid. Methods The samples were analyzed on a Grace Smart C8 （250 mm× 4.6 mm,5 μm）column and Agilent Technologies C18 （250 mm×4.6 mm,5 μm）column with 0.05 mol·L^-1 potassium dihydrogen phosphate （containing 0.1% sodium 1-heptanesulfonate, adjusted to pH 3.0 with phosphoric acid） and methanol（68 ：32） as the mobole phase.The flow rate was 1 ml·min^-1.The detection wavelength was 279 nm （para-amino benzoic acid） and 290 nm （procaine hydrochloride） respectively. The injection volume was 10 μl. Results According to the result of method verification,para amino benzoic acid could be examined by HPLC.Procaine hydrochloride was assayed by HPLC, which showed excellent line- arity within the range of 4.00--40.01μg·ml^-1.The average recovery was 101.5% （RSD= 1.5%）.Conclu- sion This method can be used to determine the content and related substances in concentrated procaine hydrochloride injection.
出处
《解放军药学学报》
CAS
CSCD
2017年第3期240-243,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
军队医疗机构制剂标准提高科研专项课题
No.13ZJZ25
关键词
浓盐酸普鲁卡因注射液
对氨基苯甲酸
HPLC
盐酸普鲁卡因
concentrated procaine hydrochloride injection
para-amino benzoic acid
HPLC
procaine hydrochloride
