反相液相色谱法测定盐酸去氧肾上腺素注射液中依地酸二钠的含量

摘要

Objective: To establish a RP-HPLC method for the quantitative analysis of disodium edetate in phenylephrine hydrochloride injection. Methods:RP-HPLC was performed using a Kromasil C8 column (4.6 mm×250 mm, 5 µm) with the mobile phase of methanol-10% tetrebutyl ammonium hydroxide-98% formic acid- water( 125:12:0.5:875) and UV detection wavelength of 254 nm at the lfow rate of 1.5 ml·min-1 and column temperature of 40℃. Results:The standard curve was linear over the range of 5.06~50.55 µg/ml (r=0.999) and the average recovery was 101.0%for disodium edetate. Conclusion:This method is simple, accurate, sensitive and good reproducible, and can be applied in the determination of disodium edetate in phenylephrine hydrochloride injection.%目的：建立盐酸去氧肾上腺素注射液中依地酸二钠含量的反相液相色谱测定方法。方法：采用Kromasil C8色谱柱（4.6 mm×250 mm，5µm），以甲醇-10%四丁基氢氧化铵溶液-98%甲酸-水（125：12：0.5：875）为流动相，流速1.5 ml/min，柱温40℃，检测波长254 nm，进样体积20µl。结果：依地酸二钠浓度在5.06～50.55µg/ml范围内与峰面积呈良好的线性关系（r=0.999），平均回收率为101.0%。结论：该方法快速、简便、专属性强、重复性好，结果准确可靠，适用于盐酸去氧肾上腺素注射液中依地酸二钠的含量测定。