RP-HPLC法测定盐酸胺碘酮包衣脉冲片中盐酸胺碘酮的含量

目的:建立测定盐酸胺碘酮包衣脉冲片中盐酸胺碘酮含量的方法。方法:采用反相高效液相色谱法。色谱柱为Agilent2C518℃柱。,流结动果相:盐为酸2%胺三碘乙酮胺检(测用浓磷度酸在调0p.H02至0～4.08).2-5乙0腈m(g·4m0L∶6-01)范,检围测内波与长峰为面积24积0n分m值,流线速性为关1系.0良mL好·(mri=n-01.,9进99样9)量,平为均20加μL样,回柱收温率为分别为99.28%、99.53%、99.85%,RSD=0.59%。结论:该方法简便、快速、准确、灵敏度高、重复性好,可用于盐酸胺碘酮包衣脉冲片的质量控制。

Content Determination of Amiodarone Hydrocholride in Amiodarone Hydrocholride Pulsatile-coated Tablets by RP-HPLC

OBJECTIVE： To establish the method for the content determination of Amiodarone hydrocholride pulsatile-coated tablets. METHODS： RP-HPLC method was adopted. The determination was performed on Agilent C18 column with mobile phase consisted of 2% triethylamine （pH adjusted to 4.8 with phosphoric acid）-acetonitrile （40 ∶ 60） with detection wavelength at 240 nm at flow rate of 1.0 mL·min-1. The column temperature was 25 ℃ and injection volume was 20 μL. RESULTS： The linear range of amiodarone hydrocholride was 0.020～0.250 mg·mL-1 （r=0.999 9） with an average recovery of 99.28%, 99.53%, 99.85% （RSD=0.59%）. CONCLUSION： The method is convenient, fast, accurate, sensitive and reproducible for the content determination of Amiodarone hydrocholride pulsatile- coated tablets.