HPLC法同时测定脂必妥片中3种Monacolin类成分的含量

目的: 建立HPLC法同时测定脂必妥片中洛伐他汀、莫纳可林L和脱水洛伐他汀3种成分的含量。 方法: 采用Agilent Zorbax SB-C₁₈(4.6 mm×250 mm,5 μm) 色谱柱,以甲醇-0.05%磷酸(78∶ 22)为流动相,流速:1.0 mL·min^-1,柱温:35 ℃,检测波长:238 nm。 结果: 洛伐他汀、莫纳可林L和脱水洛伐他汀的线性范围分别为4.18~20.88 μg·mL^-1(r=0.9998)、0.50~3.96 μg·mL^-1(r=0.9999)和1.30~6.50 μg·mL^-1(r=0.9999);加样回收率(n=9)分别为99.8%,99.5%,100.4%。 结论: 本方法简便、准确,重复性好,可用于脂必妥片中洛伐他汀、莫纳可林L和脱水洛伐他汀3种成分的含量测定。

Objective: To develop an HPLC method for simultaneous determination of monacolin K,monacolin L and dehydromonacolin K in Zhibituo tablets. Methods: An Agilent Zorbax SB-C₁₈ column (4.6 mm×250 mm,5 μm) was used with a mobile phase of methanol-0.05% phosphoric acid solution (78∶ 22).The flow rate was 1.0 mL·min^-1,the column temperature was 35 ℃,and the detection wavelength was 238 nm. Results: The linearity was obtained over 4.18-20.88 μg·mL^-1(r=0.9998) for monacolin K,0.50-3.96 μg·mL^-1(r=0.9999) for monacolin L,and 1.30-6.50 μg·mL^-1(r=0.9999) for dehydromonacolin K,respectively.The average recoveries(n=9) of monacolin K,monacolin L and dehydromonacolin K were 99.8%,99.5%,100.4%,respectively. Conclusion: The method is simple,sensitive,accurate and with high repeatability.It can be suitable for the simultaneous determination of monacolin K,monacolin L and dehydromonacolin K in Zhibituo tablets.