HPLC法测定异福片的有关物质

Determination of Related Substances in Rifampicin and Isoniazid Tablets by HPLC

目的:用高效液相色谱法测定异福片的有关物质。方法:采用C18柱,以甲醇-磷酸盐缓冲液(0.01mol.L-1磷酸二氢钾溶液,用0.1 mol.L-1氢氧化钠溶液调节pH值至7.0)(60∶40)为流动相;流量1.0 mL.min-1;检测波长254 nm;柱温30℃;进样量20μL。结果:有关物质各色谱峰与主峰之间的分离度良好,测定结果可靠。结论:本方法专属性强,灵敏度高,准确可靠,适合异福片中有关物质的检查。

Objective： To develop an HPLC method for the determination of related substances in Rifampiein and Isoniazid Tablets.Methods： It was perfomed on the Cls column, with methanol- phosphate buffer （0. 01mol ·L-1 potassium dihydrogen phosphate, adjus- ted pH value to 7. 0 with 0. 1 mol · L-1 sodium hydroxide solution） （60： 40） as mobile phase. The flow rate was 1.0 mL · min -1. The detection wavelength was 254 nm, and the column temperature was at 30 ℃. The injection volume was 20 μL. Results ： The degree of separation between any peak of related substances with main peak is good, and the determining results are reliable. Conchmion： The method was highly specific, sensitive and validated for the determination of related substances in Rifampicin and Isoniazid Tablets.