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建立了HPLC法测定双氯芬酸钾中的有关物质的方法。采用Kromasil C18(250 mm×4.6mm,5μm)色谱柱;以磷酸盐缓冲溶液(其中含0.5 g/L H3PO4,0.8 g/L NaH2PO4,用磷酸调节pH至2.5)-甲醇(34︰66)为流动相;检测波长257 nm;流速1.0 mL/min。双氯芬酸钾在0.02~0.10μg范围内线性关系良好(r=0.999 9),定量下限为4 ng,各种破坏性样品的分离度符合规定。本方法灵敏,准确,能够满足双氯芬酸钾对有关物质测定的要求。
A method for the determination of related substances in diclofenac potassium by HPLC was established. A Kromasil C18 (250 mm × 4.6 mm, 5 μm) column was used; phosphate buffer (containing 0.5 g / L H 3 PO 4, 0.8 g / L NaH 2 PO 4, adjusted to pH 2.5 with phosphoric acid) Mobile phase; detection wavelength 257 nm; flow rate 1.0 mL / min. Diclofenac potassium had a good linearity (r = 0.999 9) in the range of 0.02-0.10 μg with a lower limit of quantitation of 4 ng. The resolution of various destructive samples was within specifications. The method is sensitive and accurate, and can meet the requirements of determination of diclofenac potassium on related substances.