A Study On Method Development And Validation For The Estimation Of Anti T.B Drugs In Oral Dosage Form By Rp- Hplc1

Abstract

The pharmaceutical analysis defined as “the branch of practical chemistry which deals with the resolution, separation, identification, determination and purification of a given sample of a medicine, the detection and estimation of impurities, which may be present in drug substance (or) given sample of medicine”. Chronological order of the events that are the most notable in the development of the present state of the field. Since the various types of chromatography (liquid, gas, paper, thin-layer, ion exchange, supercritical fluid, and electrophoresis) have many features in common, they must all be considered in development of the field. Analytical method development and method validation was performed for RP-HPLC method for the Isoniazid and Rifampicin in tablet formulation as per ICH norms for the following parameters: system suitability, linearity and precision (repeatability), intermediate precision (ruggedness), specificity and accuracy. From the results obtained, it was observed that the developed method was proven to be specific, precise, linear, accurate, rugged and robust and is suitable for its intended purpose.