牙用盐酸利多卡因注射液质量控制标准研究

Quality Control of Lidocaine Hydrochloride Injection for Teeth

目的提高牙用盐酸利多卡因注射液的质量控制标准。方法增加处方中盐酸肾上腺素的鉴别;建立2,6-二甲基苯胺杂质的HPLC法检查;采用HPLC法测定处方中盐酸利多卡因的含量。结果盐酸肾上腺素的鉴别方法简单可靠;经方法学验证,2,6-二甲基苯胺杂质检查方法可行;盐酸利多卡因含量测定中,在浓度为373.62~3736.19μg·ml^(-1)范围内,线性关系良好。盐酸利多卡因的回收率为102.1%,RSD为0.9%。结论提高后的质量标准可行。

Objective To improve the standard for quality control of lidocaine hydrochloride injection for teeth.Methods Epinephrine hydrochloride was identified.2,6-dimethylaniline was examined by HPLC.A method to determine lidocaine hydrochloride by HPLC was established.Results The method of epinephrine hydrochloride identification was easy and reliable.According to the result of verification,2,6-dimethylaniline could be examined by HPLC.Lidocaine hydrochloride was assayed by HPLC,which showed excellent linearity within the range of 373.62-3736.19 μg·ml^-1.The average recovery was 102.1%（RSD =0.9%）.Conclusion This method is simple,sensitive,and with good reproducibility,which can be used to control the quality of lidocaine hydrochloride injection for teeth.