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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AgilentZorbax SB-C18(4.6 mm×250 mm,5μm)色谱柱,以甲醇-0.05%磷酸(78:22)为流动相,流速:1.0 mL.m in-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4.18～20.88μg.mL-1(r=0.9998)、0.50～3.96μg.mL-1(r=0.9999)和1.30～6.50μg.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 establish a HPLC method for the simultaneous determination of three components, Lovastatin, Monacolin L and Lovastatin Lovastatin. METHODS: The mobile phase consisted of Agilent Zorbax SB-C18 (4.6 mm × 250 mm, 5 μm) with methanol-0.05% phosphoric acid (78:22) as mobile phase at a flow rate of 1.0 mL.m in-1. Detection wavelength: 238 nm. Results: The linear range of lovastatin, monacolin L and lovastatin dehydrochloride were 4.18-20.88μg.mL-1 (r = 0.9998), 0.50-3.96μg.mL-1 (r = 0.9999) and 1.30 ~ 6.50μg.mL-1 (r = 0.9999). The average recoveries (n = 9) were 99.8%, 99.5% and 100.4% respectively. Conclusion: The method is simple, accurate and reproducible. It can be used to determine the contents of three components of lovastatin, monacolin L and lovastatin lovastatin.