HPLC测定盐酸美金刚片的含量和溶出度

Determination of content and dissolution of Memantine hydrochloride tablet by HPLC

目的采用邻苯二甲醛柱前衍生HPLC法测定盐酸美金刚片的含量和溶出度。方法样品与邻苯二甲醛衍生试剂在室温下反应3 min后,进样测定,采用Phenomenex C18色谱柱（250 mm×4.6 mm,5μm）,流动相为0.05 mol·L^-1乙酸钠（冰乙酸调p H6）-甲醇（5∶95）,流速1 mL·min^-1,检测波长338 nm。结果方法的线性范围为1-200μg·mL^-1（r=0.9998）,RSD=1.9%（n=6）;平均回收率为98.5%-100.1%;在室温条件下,衍生产物在20 min内稳定。结论所用方法简单快速、专属性好、结果准确可靠,可用于盐酸美金刚片剂的含量测定及溶出度的研究。

OBJECTIVE To establish a method for the determination of content and dissolution of Memantine hydrochloride（ MH）tablet by o- phthalaldehyde pre- column derivatization HPLC. METHODS The derivatization reaction was carried out with o-phthalaldehyde for 3 min at room temperature. Then the derivatization was separated on a Phenomenex C18（ 250 mm × 4. 6 mm,5 μm）column with the flow rate of 1. 0 mL·min^- 1and the detection wavelength of 338 nm. Mobile phase consisted of 0. 05 mol·L^- 1sodium acetate（ p H6）- methanol（ 5∶95）. RESULTS Excellent linear correlation was showed within the range of 1- 200 μg·m L- 1（ r =0. 9998）. The RSD was 1. 9%（ n = 6） and the average recovery was 98. 5%- 100. 1%. The derivatization was stable within 20 min.CONCLUSION The method is rapid,specificity,and accurate. It can be applied for content and dissolution determination of MH tablets.