Improvement of quality control of lidocaine hydrochloride injection

VernacularTitle:盐酸利多卡因注射液质量标准提高研究
Author: Zhaohui DENG ¹ ; Aihong LI ; Wenjun HU
Author Information

1. 广州军区联勤部药品仪器检验所
Keywords: lidocaine hydrochloride injection; related substances; assaying; HPLC
From: Journal of Pharmaceutical Practice 2016;(1):72-75
CountryChina
Language:Chinese
Abstract: Objective To improve the quality control standard of lidocaine hydrochloride injection .Methods A method for determination of related substances in lidocaine hydrochloride injection was established .Lidocaine hydrochloride was as‐sayed by HPLC .The chromatographic conditions :C18 chromatographic column was used .The mobile phase was phosphate buffer and acetonitrile (50∶50 ,adjusted to pH 8 with phosphoric acid) .The detection wavelength was 254 nm .Results Ac‐cording to the result of method verification ,related substances could be examined by HPLC .Lidocaine hydrochloride was as‐sayed by HPLC ,which showed excellent linearity at the range of 373 .62‐3 736 .19 μg/ml .The average recoveries were 102 .1% (RSD=0 .9% ) .Conclusion The improved standard could be used to control the quality of lidocaine hydrochloride injection .