| 洛伐他汀胶囊质量控制的高效液相色谱方法 |
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| 引用本文： | 韩媛媛,赵燕燕,李月秋,杜光玲,白洁. 洛伐他汀胶囊质量控制的高效液相色谱方法[J]. 河北大学学报(自然科学版), 2010, 30(6) |
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| 作者姓名： | 韩媛媛 赵燕燕 李月秋 杜光玲 白洁 |
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| 作者单位： | 河北大学,医学实验中心,河北,保定,071000;河北大学,医学实验中心,河北,保定,071000;河北大学,医学实验中心,河北,保定,071000;河北大学,医学实验中心,河北,保定,071000;河北大学,医学实验中心,河北,保定,071000 |
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| 基金项目： | 河北省教育厅资助项目,河北省卫生厅资助项目,河北省中医药管理局资助项目,保定市科技局科学研究与发展计划项目 |
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| 摘 要： | 利用高效液相色谱法(HPLC)建立洛伐他汀胶囊质量控制方法.采用VP-ODS(150 mm×4.6 mmi.d)柱,流动相为V(甲醇)∶V(磷酸缓冲溶液(pH=4.0))=78∶22,流速1.0 mL/min,检测波长238 nm,进样体积10μL,柱温为室温.洛伐他汀在0.004～1.000 g/L内,峰面积与质量浓度呈良好线性关系(r=0.999 9),平均回收率99.19%(n=9),方法精密度RSD为0.32%(n=6),最小检出限3 ng.该方法简单,准确,重现性好,可应用于洛伐他汀胶囊的质量控制.
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| 关 键 词： | 洛伐他汀胶囊 高效液相色谱法 质量控制 |
Quality Control of Lovastatin Capsule by HPLC |
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| HAN Yuan-yuan,ZHAO Yan-yan,LI Yue-qiu,DU Guang-ling,BAI Jie. Quality Control of Lovastatin Capsule by HPLC[J]. Journal of Hebei University (Natural Science Edition), 2010, 30(6) |
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| Authors: | HAN Yuan-yuan ZHAO Yan-yan LI Yue-qiu DU Guang-ling BAI Jie |
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| Abstract: | The quality control method was established by determinating the content and related substance of lovastatin capsule by HPLC.The VP-ODS(150 mm×4.6 mm i.d)column was used and the mobile phase was consisted of V(methanol)∶V(pH=4.0 phosphate) =78∶22,the flow rate was 1.0 mL/min,the detective wavelength was 238 nm,the injiection volumn was 10 μL,the column temperature was room temperature.A good linearity(r =0.999 9) was obtained in the concentration range of 0.004～1.000 g/L,and the average recovery of lovastatin was 99.19%(n=9).The method precision was 0.32%(n=6),and the lowest examination limits was 3 ng.The method is simple,accurate and reproducible.It can be applied for the quality control of lovastatin capsule. |
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| Keywords: | lovastatin capsule HPLC quality control |
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