离子对反相高效液相色谱法测定异福酰胺片中异烟肼及吡嗪酰胺含量

Determination the Content of isoniazid and Pyrazinamide in Tablets by Ion-pair RP-HPLC

目的:建立用离子对反相HPLC法同时测定异福酰胺片中异烟肼、吡嗪酰胺的含量。方法:反相高效液相色谱法。色谱柱为μBondapak C18色谱柱(10μm,4.6 mm×250 mm),流动相为乙腈-0.1%庚烷磺酸钠-水(10:30:60),pH 2.5,检测波长254 nm,流速:1.0 ml·min-1。外标法测定异烟肼、吡嗪酰胺的含量。结果:线性范围为异烟肼和吡嗪酰胺分别在0.013- 0.06 mg·ml-1和0.04-0.18 mg·ml-1范围内线性关系良好。异烟肼平均回收率99.3%(RSD 0.30%),吡嗪酰胺99.2%(RSD 0.3%)。结论:本方法准确、快速、可靠、灵敏,可作为该制剂质量检验方法。

Objective: To established an ion-pair RP-HPLC method for content determination of isoniazid and pyrazinamide in tablets. Method: An μ Bondapak C18 column(10 μm, 4.6 mm×250 mm) was used. The mobile phase was acetonitrile-0. 1% soldium heptanesulfonate-water( 10:30: 60) ,pH 2.5, the flow rate was 1. 0 ml·min-1, the detecting wavelength was at 254 nm. Result: The isoniazid and pyrazinamide presented a good linear correlation with in a ranges of 0.013-0.06 mg·ml-1 and 0.04-0.08 mg·ml-1, r = 0.999 7,respectively,the average recoveries were 99.3% RSD 0.3% and 99.2% RSD 0.3% . Conclusion: This method is simple and accurate for quantitative determination of the preparation.