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[摘要]
目的 建立RP-HPLC梯度洗脱法测定阿托伐他汀钙原料药中阿托伐他汀钙。方法 Symmetry shield RP-C18色谱柱(250 mm×4.6 mm,5 μm);以磷酸盐缓冲液(pH值2.5)为流动相A,乙腈–甲醇–水(770∶50∶180)为流动相B,进行线性梯度洗脱;检测波长246 nm;柱温40 ℃;体积流量1.0 mL/min;进样体积20 μL。结果 阿托伐他汀钙线性范围为10.655~31.965 μg/mL(r=0.999 8),平均回收率为98.2%,RSD值为0.23%(n=6)。结论 该方法准确可靠,专属性强,稳定性高,可更好地控制阿托伐他汀钙原料的质量。
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[Abstract]
Objective To establish a gradient elution method of RP-HPLC to determine atorvastatin calcium in atorvastatin calcium bulks drug. Methods The column was Symmetry shield RP-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of a KH2PO4 buffer (adjust the pH value to 2.5) (A) and methanol - acetonitrile - water (50∶770∶180) (B). The detection wavelength was 246 nm and the column temperature was 40 ℃. The flow rate was 1.0 mL/min with 20 μL injection volume. Results Atorvastatin calcium had a good linearity in the range of 10.655 — 31.965 μg/mL (r=0.999 8). The average recovery was 98.2% with RSD 0.23% (n= 6). Conclusion The method is accurate, reliable, sensitive, and reproducible, which could be used for the quality control of atorvastatin calcium bulks drug.
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