瑞舒伐他汀钙原料药中有关物质的测定 |
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引用本文: | 汪涛,丁立秀,马哲,郑士灼,张彩娟,牛锋.瑞舒伐他汀钙原料药中有关物质的测定[J].国外医药(植物药分册),2014(6):603-606. |
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作者姓名: | 汪涛 丁立秀 马哲 郑士灼 张彩娟 牛锋 |
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作者单位: | 石药集团欧意药业有限公司;石药集团中诺药业(石家庄)有限公司;石药集团恩必普药业有限公司; |
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基金项目: | 国家科技重大专项资助项目(2011ZX09203-002) |
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摘 要: | 目的 建立高效液相色谱(HPLC)法测定瑞舒伐他汀钙原料药中有关物质的方法。方法 采用HPLC法,Phenomenex Luna C18 (2)色谱柱(250 mm×4.6 mm,5 μm),流动相为水-乙腈-1%三氟乙酸水溶液(62:37:1),体积流量为1.0 mL/min,柱温为40℃,进样量为20 μL,检测波长为242 nm。结果 系统和方法精密度RSD值均小于20%(n=6),瑞舒伐他汀钙在0.020 1~0.201 3 μg线性关系良好(r=0.999 8),瑞舒伐他汀钙的检测限为2.76 ng,各杂质氧化产物、内酯、光降解产物Ⅰ和Ⅱ和非对映异构体各杂质的检测限依次为1.85、1.32、1.08、1.11、2.06 ng。结论 本法合理严谨,精密度好,检测灵敏度高,可有效用于瑞舒伐他汀钙有关物质检测。
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关 键 词: | 瑞舒伐他汀钙原料药 瑞舒伐他汀钙 有关物质 高效液相色谱 |
Determination of related substances in rosuvastatin calcium bulks drug |
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Authors: | WANG Tao DING Li-xiu MA Zhe ZHENG Shi-zhuo ZHANG Cai-juan NIU Feng |
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Institution: | 1. Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd., Shijiazhuang 050000, China;2. Shijiazhuang Pharma Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Shijiazhuang 050000, China;3. Shijiazhuang Pharma Group NBP Pharmaceutical Co., Ltd., Shijiazhuang 050000, China) |
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Abstract: | Objective To establish an HPLC method for detecting the related substances ofrosuvastatin calcium. Methods HPLC was carried out on Phenomenex Luna C18 (2) column (250 mm× 4.6 mm, 5 μm) with water - acetonitrile - 1% trifluoroacetic acid (62 : 37 : 1) as mobile phase. The detection wavelength was 242 nm and injection volume was 20 μL at the flow rate of 1.0 mL/min. The column temperature was set for 40 ℃. Results The RSD values of method precision and system precision were less than 20% (n=6). The rosuvastatin calcium had a good linearity in the range of 0.020 1 μg - 0.201 3 μg (r=0.999 8). The detection limit of rosuvastatin calcium was 2.76 ng and the detection limits of impurity were oxidation product (1.85 ng), rosuvastatin lactone (1.32 ng), photodegradation product Ⅰ (1.08 ng), photodegradation product Ⅱ (1.11 ng), non enantiomer (2.06 ng), respectively. Conclusion The method with good precision and high sensitivity could be used for detecting the related substances of rosuvastatin calcium. |
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Keywords: | rosuvastatin calcium bulks drug rosuvastatin calcium related substance HPLC |
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