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目的建立双氯芬酸钠栓剂含量测定方法。方法采用反相高效液相色谱法测定该制剂中双氯芬酸钠的含量,色谱柱为Symnetry-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水-36%醋酸(82∶17∶1.0),检测波长279 nm,流速为1.0 mL.min-1,柱温25℃。结果双氯芬酸钠浓度在8~40μg.mL-1内线性关系良好(r=0.999 1),平均回收率为97.13%,RSD为1.1%(n=6)。结论该法结果准确,重复性好,为该栓剂制订质量标准提供了科学的方法学参考。
Objective To establish a method for the determination of diclofenac sodium suppositories. Methods The content of diclofenac sodium was determined by reversed-phase high performance liquid chromatography. The column was Symnetry-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-water-36% acetic acid 1.0). The detection wavelength was 279 nm and the flow rate was 1.0 mL.min-1. The column temperature was 25 ℃. Results The diclofenac sodium concentration was good in the range of 8 ~ 40μg.mL-1 (r = 0.999 1). The average recovery was 97.13% and the RSD was 1.1% (n = 6). Conclusion The method is accurate and reproducible. It provides a scientific methodological reference for setting quality standards for this suppository.