Analytical Method Development and Validation for Thioacetazone and Isoniazide (INH) by using RP-HPLC in Pharmaceutical Dosage forms as per ICH Guidelines

Abstract

This research workoutlines the advancement& verification of a HPLC technique for the parallel quantification of Isoniazid & Thiaacetazone. The optimized chromatographic conditions employed a SPURSIL C18-EP column with a MP composed of 66% HCOOH &34% ACN, a flow speed of 1 ml per min, & detection at 260 nm. SST demonstrated that all parameters, including resolution (greater than 2), theoretical plates (above 2000), & tailing factor (below 2), met the required consent. The assay results showed a % assay of 99.55% for Isoniazid & 98.31% for Thiaacetazone. The technique exhibited linearity over the conc. extent of 10–50 µg per ml for both compounds, with R2 of 0.9998 & 0.9994, separately. Precision studies indicated low %RSD values (0.9% for Isoniazid & 1.5% for Thiaacetazone), confirming the method's reliability. LOD were determined at 1.6 ppm for Isoniazid & 1.5 ppm for Thiaacetazone, while LOQ were found to be 5.6 ppm & 5.4 ppm, separately. Robustness testing revealed that variations in flow speed & MP composition didn’t notable affect the technique performance. Overall, the verified HPLC technique is suitable for regular QC of Isoniazid &Thiaacetazone in formulations.