| 盐酸利多卡因注射液质量标准提高研究 |
| 投稿时间：2015-02-05 修订日期：2015-06-03 点此下载全文 |
| 引用本文：邓朝晖,李爱红,胡文军.盐酸利多卡因注射液质量标准提高研究[J].药学实践杂志,2016,34(1):72~75 |
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| 基金项目:军队医疗机构制剂标准提高科研专项课题(13ZJZ25) |
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| 中文摘要: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。 |
| 中文关键词:盐酸利多卡因注射液 有关物质检查 含量测定 高效液相色谱法 |
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| Improvement of quality control of lidocaine hydrochloride injectio |
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| 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. |
| keywords:lidocaine hydrochloride injection related substances assaying HPLC |
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