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目的:建立HPLC法测定异烟肼维B6片中异烟肼、维生素B6含量的方法。方法:采用Agilent Eclipse Plus C18(250mm×4.6 mm,5μm)色谱柱,以0.1%三乙胺溶液(加入20 mg辛烷磺酸钠,用磷酸调节pH至3.0±0.05)-甲醇(70∶30)为流动相,进样量为10μl,检测波长为291nm,流速为1.0 ml·min-1,柱温为30℃。结果:异烟肼、维生素B6分别在2.535~50.70μg(r=1.000 0)、0.136 8~2.735μg(r=1.000 0)范围内线性关系良好,平均回收率分别为99.57%(RSD=0.89%)、99.59%(RSD=0.43%)(n=9)。结论:本法专属性强、结果准确、灵敏、操作简便,可用于本品的质量控制。
Objective: To establish a HPLC method for the determination of isoniazid and vitamin B6 in isoniazid and vitamin B6 tablets. Methods: The samples were separated on a Agilent Eclipse Plus C18 (250 mm × 4.6 mm, 5 μm) column with 0.1% triethylamine (20 mg sodium octane sulfonate and pH adjusted to 3.0 ± 0.05 with phosphoric acid) -methanol (70:30 ) As the mobile phase. The injection volume was 10μl, the detection wavelength was 291nm, the flow rate was 1.0 ml · min-1 and the column temperature was 30 ℃. Results: The calibration curves of isoniazid and vitamin B6 showed good linearity in the range of 2.535-50.70μg (r = 1.000 0) and 0.136-8-2.735μg (r = 1.000 0), with the average recoveries of 99.57% (RSD = 0.89% ), 99.59% (RSD = 0.43%) (n = 9). Conclusion: This law is specific, accurate, sensitive, easy to operate, can be used for the quality control of this product.