Improvement of quality control of lidocaine hydrochloride injectio
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摘要: 目的 提高盐酸利多卡因注射液的质量控制标准。 方法 采用高效液相色谱法代替原容量分析法测定盐酸利多卡因注射液中盐酸利多卡因的含量。采用的色谱条件均以十八烷基硅烷键合硅胶为填充剂;以磷酸盐缓冲液-乙腈(50:50,用磷酸调节pH值至8.0)为流动相;检测波长为254 nm。 结果 经方法学验证,该色谱条件可用于盐酸利多卡因注射液中有关物质的检查;盐酸利多卡因含量测定中,在浓度为373.62~3 736.19 μg/ml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。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 assayed 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 According to the result of method verification, related substances could be examined by HPLC.Lidocaine hydrochloride was assayed 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.
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Key words:
- lidocaine hydrochloride injection /
- related substances /
- assaying /
- HPLC
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