HPLC法测定对氨基水杨酸异烟肼中异烟肼的含量及有关物质的研究

HPLC Study on Determination for Isoniazid Content in Isoniazid Aminosalicylate and Its Related Compounds

目的:建立 HPLC 法测定对氨基水杨酸异烟肼中异烟肼的含量及有关物质。方法:采用 Hypersil BDS-C_(18)(4.6mm×250min,5μm)色谱柱,甲醇-0.02moL·L^(-1)磷酸氢二钠(用磷酸调 pH 为6.0)(20:60);流速:0.8 mL·min^(-1);检测波长:254nm;柱温为室温;结果:异烟肼及3-氨基酚分别在4.058～40.58μg·mL^(-1)和0.09272～1.854μg·mL^(-1)范围内呈良好的线性关系;异烟肼平均回收率为99.6%;异烟肼及3-氨基酚的最低定量限分别为0.02ng 和0.90ng。结论:本法简便、准确,专属性好,灵敏度高,可用于对氨基水杨酸异烟肼中异烟肼的含量及有关物质的测定。

Objective： To establish an HPLC method to determine Isoniazid content in Isoniazid Aminosalicylate and its related compounds. Method：The HPLC method was conducted on a Hypersil BDS -C18 column （4.6 mm × 250 mm,5μm）and coupled UV detector at 254 nm, using methanol -0. 02 moL · L^-1 Na2HPO4 buffer（ adjusted to pH 6. 0 with phosphoric acid,20： 60） as mobile phase,the flow rate was 0. 8 mL · L^-1 and the column temperature was room temperature. Result：. The linear ranges of Isoniazid and 3 - aminohydroxybenzene were 4. 058 - 40. 58μg · L^-1and 0. 09272 - 1. 854 μg · L^-1 ,respectively. The average recovery of Isoniazid was 99.6%. The LOD of Isoniazid and 3 - aminohydroxybenzene were 0. 02 ng and 0. 90 ng, respectively. Condution： A simple, accurate and sensitive HPLC method to determine Isoniazid content in Isoniazid Aminosalicylate and its related compounds was established.