高效液相色谱法测定异烟肼片剂制剂中的异烟肼和1-异烟酰基-2-乳糖酰肼

High-performance liquid chromatographic determination of isoniazid and 1-isonicotinyl-2-lactosylhydrazine in isoniazid tablet formulations.

作者信息

Butterfield A G, Lovering E G, Sears R W

出版信息

J Pharm Sci. 1980 Feb;69(2):222-4. doi: 10.1002/jps.2600690233.

Abstract

A high-performance liquid chromatographic procedure is presented for the simultaneous determination of isoniazid and 1-isonicotinyl-2-lactosylhydrazine (I) in isoniazid tablet formulations. An aliquot of a diluted aqueous tablet extract is introduced onto a microparticulate cyanopropyl bonded-phase column using a valve-loop injector and chromatographed using a mobile phase of acetonitrile--0.01 M, pH 3.5 aqueous acetate buffer (5:95). Compound I can be determined at levels as low as 0.5% of the isoniazid label claim. The relative standard deviations are 0.4 and 0.7% for the simultaneous determination of isoniazid and I, respectively. Seven commercial tablet formulations contained 93.8--97.0% of the labeled isoniazid amounts and 0.3--5.8% of I, expressed as equivalent isoniazid relative to the labeled isoniazid level.

摘要

本文介绍了一种高效液相色谱法，用于同时测定异烟肼片剂制剂中的异烟肼和1-异烟酰基-2-乳糖酰肼（I）。使用阀进样器将稀释的片剂水提取物的等分试样注入微粒氰丙基键合相柱，并使用乙腈-0.01M、pH3.5的乙酸盐水溶液缓冲液（5:95）作为流动相进行色谱分析。化合物I的测定水平可低至异烟肼标签声明量的0.5%。同时测定异烟肼和I时，相对标准偏差分别为0.4%和0.7%。七种市售片剂制剂中异烟肼含量为标示量的93.8%-97.0%，I含量为0.3%-5.8%，以相对于标示异烟肼水平的等效异烟肼表示。