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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 quality control standard of dental lidocaine hydrochloride injection. Methods To increase the prescription of epinephrine hydrochloride; to establish 2,6-dimethylaniline impurity by HPLC method; HPLC method for the determination of lidocaine hydrochloride content. Results The method of identification of epinephrine hydrochloride was simple and reliable. The method of impurity detection of 2,6-dimethylaniline was validated by methodological validation. In the determination of lidocaine hydrochloride, the concentration of epinephrine hydrochloride was 373.62 ~ 3736.19μg · ml -1, Within the range, the linear relationship is good. The recovery of lidocaine hydrochloride was 102.1% with RSD of 0.9%. Conclusion The improved quality standard is feasible.