HPLC法测定异烟肼维B6片中两组份的含量

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。

Quantitative Determination of Two Components in Isoniazid and Vitamin B6 Tablets by HPLC

Objective： To establish a determination method for isoniazid and vitamin B6 tablets by HPLC. Methods： The procedure was performed on an Agilent Eclipse Plus C18（ 250 mm ×4.6 mm,5 μm） column at 30℃ and the detection wavelength was 291 nm. The mobile phase was composed of 0. 1% triethylamine in which 20 mg sodium 1-octanesulfonate was added and the pH value was adjusted to（ 3. 0 ± 0. 05） by phosphoric acid]and methanol（ 70∶ 30） at a flow rate of 1. 0 ml·min- 1,and the injection volume was 10 μl. Results： The linear range of isoniazid and vitamin B6 was within the range of 2. 535-50. 700 μg（ r = 1. 000 0） and 0. 137-2. 735 μg（ r = 1. 000 0）,respectively. The mean recovery was 99. 57%（ RSD = 0. 89%） and 99. 59%（ RSD = 0. 43%）（ n = 9）,respectively. Conclusion： The method is specific,accurate,sensitive and simple,which is applicable in the quality control of isoniazid and vitamin B6 tablets.