HPLC法同时测定重酒石酸去甲肾上腺素注射液和盐酸去氧肾上腺素注射液的含量及有关物质(1)
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摘 要 目的：建立测定重酒石酸去甲肾上腺素注射液和盐酸去氧肾上腺素注射液含量及有关物质的方法。方法：采用高效液相色谱法，色谱柱：Kromasil C18色谱柱(4.6 mm×250 mm，5 µm)；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：1 ml/min；柱温：30 ℃。结果：重酒石酸去甲肾上腺素在80～320 μg/ml范围内与峰面积呈良好的线性关系，r=0.999 8；高、中、低3种浓度的平均回收率为101.2%，RSD为0.18%(n=9)。重酒石酸去甲肾上腺素的最小检测限为152.3 ng/ml。盐酸去氧肾上腺素在100～400 μg/ml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98.1%，RSD为0.051%(n=9)。盐酸去氧肾上腺素的最小检测限为103.8 ng/ml。结论：该法简便、准确、灵敏度高，重现性好，可用于重酒石酸去甲肾上腺素注射液和盐酸去氧肾上腺素注射液的含量测定和有关物质检查。
关键词 高效液相色谱法 重酒石酸去甲肾上腺素 盐酸去氧肾上腺素 注射液 含量测定 有关物质
中图分类号：O657.72；R927.2 文献标识码：A 文章编号：1006-1533(2012)07-0038-04
Simultaneous determination of both norepinephrine bitartrate injection and phenylephrine 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 methods for the determination of both norepinephrine bitartrate injection and phenylephrine hydrochloride injection and their related substances. Methods: An HPLC was performed on a column of Kromasil C18 (250 mm×4.6 mm,5 μm) with the mobile phase of methanol - acetonitrile - sodium heptane solution (1：1：8) at detection wavelength of 280 nm, flow rate of 1.0 ml/min and column temperature of 30 ℃. Results: For norepinephrine bitartrate, the calibration curve was linear (r=0.999 8) over the range of 80～320 μg/ml, the average recovery was 101.2% with RSD 0.18% and the limit of detection was 152.3 ng/ml. For phenylephrine hydrochloride, the calibration curve was linear (r=0.999 6) over the range of 100～400 μg/ml, the average recovery was 98.1% with RSD 0.051% and the limit of detection was 103.8 ng/ml. Conclusion: This method is simple, accurate, sensitive and good reproducible, which can be applied in the determination of both norepinephrine bitartrate injection and phenylephrine hydrochloride injection and their related substances.
KEY WORDS HPLC； norepinephrine bitartrate ；phenylephrine hydrochloride； injection；assay； related substances
重酒石酸去甲肾上腺素和盐酸去氧肾上腺素均为肾上腺素受体激动药，具有收缩血管的作用。临床上用于治疗休克及维持血压。重酒石酸去甲肾上腺素注射液[1]和盐酸去氧肾上腺素注射液[2]均为《中国药典》2010年版二部收载品种 ......
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