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目的建立HPLC法测定非洛地平缓释片的含量。方法采用大连依利特ODS-2(5μm,4.6 mm×250 mm)色谱柱;乙腈-甲醇-磷酸盐缓冲液(pH 3.0)(2∶1∶2)为流动相,流速为1.0 mL/min,检测波长为254 nm,进样体积为20μL。结果非洛地平在9.72~29.16 mg/L浓度范围内与峰面积呈良好的线性关系(r=0.999 8)。平均回收率为100.3%,RSD为0.87%(n=9)。结论该方法简便、灵敏、准确,可用于非洛地平缓释片的质量控制。
Objective To establish a HPLC method for the determination of felodipine sustained-release tablets. Methods The column of ODS-2 (5μm, 4.6 mm × 250 mm) was used in this study. The mobile phase consisted of acetonitrile-methanol-phosphate buffer pH 3.0 (2:1:1) The detection wavelength was 254 nm and the injection volume was 20 μL. Results Felodipine showed a good linear relationship with the peak area in the range of 9.72-29.16 mg / L (r = 0.999 8). The average recovery was 100.3% with a RSD of 0.87% (n = 9). Conclusion The method is simple, sensitive and accurate and can be used for the quality control of felodipine sustained-release tablets.