反相高效液相色谱法测定双氯芬酸钾片的含量及有关物质

Determination of content and related substances of diclofenac potassium tablets by RP-HPLC

目的 :研究反相高效液相色谱法测定双氯芬酸钾片的含量及有关物质。方法 :HypersilODSC18色谱柱 (2 5 0mm× 4 .6mm ,5 μm ) ,以甲醇 磷酸盐缓冲液 (6 6∶34)为流动相 ,流速 1.0mL·min- 1,检测波长为 2 80nm。结果 :A =30 .2 2 8C + 5 0 .95 6 (r=0 .9994 ,n =5 ) ,线性范围为 4 0 .16～ 6 0 .2 4mg·L- 1;最低检出限为 0 .39ng ;平均方法回收率为99 .33% (RSD =1.5 7% ) ;日内、日间RSD均 <5 %。结论 :采用反相HPLC法测定双氯芬酸钾片的含量及其有关物质方法简便 。

AIM: To determine the content and the related substances of diclofenac potassium tablets by RP-HPLC. METHODS: Hypersil ODS C 18 column (250 mm×4.6 mm, 5 μm) was used with mobile phase methanol-phosphate buffer (equal volumes of 0.16 % w/v solution of sodium dihydrogen orthophosphate and 0.10 % w/v solution of orthophosphoric acid, adjusted to pH 2.5)(66∶34). Flow rate was 1.0 mL·min -1 and detective wave length was 280 nm. RESULTS: The linear range of the determination by RP-HPLC was 40.16-60.24 mg·L -1. The correlation coefficient was 0.9994. The least detective range was 0.39 ng. The intra-day RSD and inter-day RSD were less than 5 %. CONCLUSION: The method to determine the content and the related substances of diclofenac potassium tablets by RP-HPLC is easy to operate and the results of the determination is accurate.