Analytical Method Development and Validation for the Determination of Isoniazid in, Isoniazid and Ethambutol Hydrochloride Tablets

A simple method using HPLC system for the quantification of Isoniazid, in a fixed-dose combination (FDC) of anti-tuberculosis drug product was developed and validated. The chromatographic separation of Isoniazid (INH) was carried out using Waters Symmetry C8 column (150× 4.6 mm: Particle size: 5 μm), UV detection at 262 nm, and an isocratic system with composed of mobile phase of Phosphate buffer solution (pH 6.8) and Acetonitrile in the ratio of 980: 20, at a flow rate of 1.0 mL/min. The retention time of Isoniazid was about 3.8 minutes.