| 引用本文: | 张轶华,郭永辉,韩彬,姜建国.HPLC测定瑞舒伐他汀钙片中的有关物质[J].中国现代应用药学,2015,32(5):582-585. |
| ZHANG Yihua,GUO Yonghui,HAN Bin,JIANG Jianguo.Determination of the Related Substances of Rosuvastatin Calcium Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(5):582-585. |
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| 摘要: |
| 目的 建立瑞舒伐他汀钙片有关物质的高效液相色谱测定方法。方法 采用Diamonsil C18(4.6 mm×250 mm，5 μm)色谱柱，以乙腈-0.02 mol·L-1醋酸铵缓冲液(冰醋酸调节pH至4.0±0.05)(50∶50)为流动相，流速为1.0 mL·min-1，检测波长为242 nm。结果 瑞舒伐他汀在0.05~0.5 mg·mL-1内线性关系良好(r=1.000 0)，有关物质与主药分离良好，瑞舒伐他汀、非对映体、氧化降解产物、光降解产物和内酯的检出限分别为4，20，300，200和15 ng。结论 该方法操作简单，重复性好，专属性强，可用于瑞舒伐他汀的有关物质检查。 |
| 关键词: 瑞舒伐他汀 高效液相色谱法 有关物质 |
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| Determination of the Related Substances of Rosuvastatin Calcium Tablets by HPLC |
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ZHANG Yihua, GUO Yonghui, HAN Bin, JIANG Jianguo
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Hebei Institute for Drug Control, Shijiangzhuang 050011, China
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| Abstract: |
| OBJECTIVE To establish a method for determination of the related substances of rosuvastatin calcium tablets by HPLC. METHODS A Diamonsil C18 column (4.6 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-0.02 mol·L-1 ammonium acetate (50∶50, adjust pH to 4.0±0.05 with glacial acetic acid) at a flow rate of 1.0 mL·min-1, and the detection wavelength was 242 nm. RESULTS The resolutions of rosuvastatin and other related substances were good, and the linear range of rosuvastatin was 0.05-0.5 mg·mL-1(r=1.000 0). The limit quantitation of rosuvastatin, diastereomer, oxidative breakdown product, photodegradation product and inner ester were 4, 20, 300, 200, 15 ng. CONCLUSION The method is convenient, accurate and exclusive for the determination of related substances of rosuvastatin. |
| Key words: rosuvastatin HPLC related substances |
