高效液相色谱法测定盐酸异丙肾上腺素注射液的含量

Determination of Isoprenaline Hydrochloride Injection by HPLC

目的建立高效液相色谱(HPLC)法用于测定盐酸异丙肾上腺素注射液的含量。方法以Agilent EclipseXDB-C18柱(250mm×4.6mm,5μm)为分析柱,以用磷酸调pH=3.0的0.14%庚烷磺酸钠溶液-甲醇(65∶35)为流动相,流速为1.0mL/min,检测波长为280nm,柱温为室温。结果盐酸异丙肾上腺素质量浓度在25.0～625.2μg/mL范围内与峰面积线性关系良好,回归方程为A=565563.275C-2.625,r=0.9999(n=7),平均回收率为99.76%,RSD为0.51%(n=6)。结论HPLC法操作简便、结果准确、重现性好,可用于盐酸异丙肾上腺素注射液的含量测定。

Objective To establish a HPLC method for the determination of Isoprenaline hydrochloride Injection. Methods The sample was separated on a Agilent Eclipse XDB-C18（250 mm×4.6 mm, 5 μm） by a gradient elution program with 0. 14% sodium heptanesulfonate- methanol （65：35, adjusted to pH =3.5 with phosphoric acid） as the mobile phase at the flow rate of 1.0 mL/min. The detection wavelength was at 280 nm. and the temperature of the column was the ambient temperature. The standard curve method was used for the quantitative detection of isoprenaline hydrochloride. Results The standard curve for isoprenaline hydrochloride was linear in the range of 25.0 - 625.2 μg/mL. The regression equation was A = 565 563. 275 C - 2. 625, r = 0. 999 9 （ n = 7）. The recovery rate was 99. 76%, RSD was 0. 51% （n =6）. Conclusion The method is easy, accurate and reproducible. It can be used for the content determination of Isoprenaline Hydrochloride Injection.