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目的采用HPLC测定片剂中阿戈美拉汀的含量。方法色谱柱为Phenomenex Luna-C18(250 mm×4.6 mm,5 m),流动相为甲醇-0.05 mol.L 1磷酸二氢钠溶液(40∶60),流速为1.0 mL.min 1,检测波长为230 nm,柱温为25℃。结果线性回归方程为Y=1.979×105X-1.258×104(r=0.999 9,n=5),线性范围为1.07~10.7 g.mL 1,平均回收率为98.73%(n=9),RSD为1.28%。结论所建方法简便、准确、专属,可用于片剂中阿戈美拉汀的含量测定。
Objective To determine the content of agomelatine in tablets by HPLC. Methods The mobile phase was Phenomenex Luna-C18 (250 mm × 4.6 mm, 5 m). The mobile phase was methanol-0.05 mol·L -1 sodium dihydrogen phosphate solution (40:60) at a flow rate of 1.0 mL · min -1. The detection wavelength 230 nm, column temperature 25 ℃. Results The linear regression equation was Y = 1.979 × 105X-1.258 × 104 (r = 0.999 9, n = 5) with a linear range of 1.07-10.7 g.mL 1 and an average recovery of 98.73% (n = 9) 1.28%. Conclusion The method is simple, accurate and specific and can be used for the determination of agomelatine in tablets.