李　晗，李继斌，邢正英，戴学文，房志仲（天津医科大学药学院，天津市临床药物关键技术重点实验室，天津　300070）



复方阿托伐他汀依折麦布胶囊的质量控制

李晗，李继斌，邢正英，戴学文，房志仲
（天津医科大学药学院，天津市临床药物关键技术重点实验室，天津300070）

摘要目的：建立复方阿托伐他汀依折麦布胶囊的质量控制方法。方法：利用HPLC法测定复方阿托伐他汀依折麦布胶囊中主药的含量与制剂的含量均匀度，色谱条件为：TIANHE誖Kromasil C(18)色谱柱（200 mm×4.6 mm，5 μm）；流动相为甲醇-0.05 mol/L KH2PO4（磷酸调节pH至3.0）-乙腈（5∶45∶50）；检测波长为λ=236 nm；流速1.0 mL/min；进样量20 μL；柱温为25℃。结果：阿托伐他汀在1.12～16.8 μg/mL的浓度范围内线性关系良好（r=0.999 9），依折麦布在1.14～17.1 μg/mL的浓度范围内线性关系良好（r=0.999 9）；阿托伐他汀和依折麦布的平均加样回收率分别为100.58%和100.64%，RSD分别为1.18%和0.92%。结论：该HPLC测定条件和含量测定方法能够有效地测定样品的含量，且简便易行。

关键词阿托伐他汀；依折麦布；高效液相色谱法；质量控制；含量均匀度

Quality control of compound atorvastatin and ezetimibe capsule

LI Han,LI Ji-bin,XING Zheng-ying,DAI Xue-wen,FANG Zhi-zhong
（College of Pharmacy,Tianjin Medical University,Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics(Theranostics),Tianjin 300070,China）

Abstract Objective:To establish an appropriate method to determine contents of atorvastatin and ezetimibe in compound atorvastatin and ezetimibe capsule.Methods:Content and content uniformity of compound atorvastatin and ezetimibe capsule were determined by an HPLC method,in which a TIANHE誖Kromasil C18column(200 mm×4.6 mm,5 μm)was used as stationary phase and a mix of methanol-0.05 mol/L KH2PO4(adjusted to pH 3.0 with phosphoric acid)-acetonitrile(5∶45∶50)was used as mobile phase.The detection wavelength was 236 nm and flow rate was 1.0 mL/min.Column temperature was set at 25℃.Results:The concentration detection of atorvastatin showed a fine linearity between 1.12-16.8 μg/mL(r=0.999 9),while the concentration detection of ezetimibe showed a fine linearity between 1.14-17.1 μg/mL(r=0.999 9);the average recoveries of atorvastatin and ezetimibe were 100.58% and 100.64%,respectively,and corresponding RSD values were 1.18% and 0.92%,respectively.Conclusion:The detection method in this study is simple and accuracy,so it is appropriate to be used in the quality control of the compound atorvastatin and ezetimibe capsule.

Key words atorvastatin；ezetimibe；HPLC；quality control；content uniformity

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