DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ISONIAZID IN BULK AND TABLET DOSAGE FORM

Abstract

The aim of present study is to develop simple, sensitive, accurate, rapid and precise reverse phase High Performance Liquid Chromatography (RP-HPLC) method for estimation of isoniazid in bulk drug and pharmaceutical dosage forms. The chromatographic separation was achieved on Neosphere C₁₈ (150×4.6mm, i.d.3µ) column. The Analytical method was developed by using mobile phase consisting of 0.010 M potassium dihydrogen orthophosphate: methanol (85:15 v/v). The flow rate and detection wavelength was 1ml/min and 253 nm respectively. The retention time was 2.975±0.054min. The response of the drug was found to be linear in the range of 15-90 µg/ml (r²>0.999). Isoniazid was subjected to acid, alkali, neutral, dry heat, photostability and oxidative degradation. The LOD and LOQ were 0.671 and 2.033 µg/ml respectively. There was no interference of any degradants and excipients in determination of drugs in marketed formulation and it could effectively separate the drug from its degradation products and it can be successfully employed for routine analysis.