HPLC法同时测定盐酸异丙肾上腺素注射液及盐酸肾上腺素注射液含量及有关物质.docVIP

HPLC法同时测定盐酸异丙肾上腺素注射液及盐酸肾上腺素注射液含量及有关物质摘 要 目的：建立测定盐酸异丙肾上腺素注射液和盐酸肾上腺素注射液的含量及有关物质的方法。方法：采用高效液相色谱法，色谱柱：Welch Materials C18色谱柱(4.6 mm×150 mm，5 micro;m)；流动相：甲醇-乙腈-庚烷磺酸钠溶液（1∶1∶8）；检测波长：280 nm；流速：2.0 mlmin-1；柱温：30 ℃。结果：盐酸异丙肾上腺素在10～40 micro;gml-1质量浓度范围内与峰面积呈良好的线性关系，r=0.999 9；高、中、低3种浓度的平均回收率为100.5%，RSD为0.76%（n=9）。盐酸异丙肾上腺素的最小检测限为40.66 ngml-1。盐酸肾上腺素在60～240 micro;gml-1质量浓度范围内与峰面积呈良好的线性关系，r=0.999 6；高、中、低3种浓度的平均回收率为100.2%，RSD为0.60%（n=9）。盐酸肾上腺素的最小检测限为44.12 ngml-1。结论：该法简便、快速、准确、灵敏度高，重现性好，适用于盐酸异丙肾上腺素注射液和盐酸肾上腺素注射液的含量测定，也可用于有关物质检查。 关键词 高效液相色谱法 盐酸异丙肾上腺素 盐酸肾上腺素 注射液 含量测定 有关物质 中图分类号：R927.2 文献标识码：A 文章编号：1006-1533(2012)05-0041-04 Simultaneous determination of both isoprenaline hydrochloride injection and epinephrine hydrochloride injection and their related substances by HPLC method SUN Ke-gang , SHI Jian-guo* , JIANG Yu-dan (Shanghai Harvest Pharmaceutical Co.,Ltd, Shanghai,201206) ABSTRACT Objective: To establish a method for the determination of both isoprenaline hydrochloride injection and epinephrine hydrochloride injection and their related substances. Method: An HPLC was performed on a column of Welch Materials C18 (150 mm×4.6 mm,5 μm) with the mobile phase of methanol- acetonitrile ? sodium heptanesulfonate solution (1∶1∶8) at detection wavelength of 280 nm. Results: For isoprenaline hydrochloride, the calibration curve was linear (r=0.999 9) over the range of 10～40 micro;g?ml-1, the average recovery was 100.5% with RSD 0.76% and the limit of detection was 40.66 ng?ml-1. For epinephrine hydrochloride, the calibration curve was linear (r=0.999 6) over the range of 60～240 micro;gml-1, the average recovery was 100.2% with RSD 0.60% and the limit of detection was 44.12 ng?ml-1. Conclusion: This method is simple, rapid, accurate, high sensitive and good reproducible, which can be applied in the determination of both isoprenaline hydrochloride injection and epinephrine hydrochloride injection and their related substances. KEY WORDS HPLC； isoprenaline hydrochloride；epinep