Abstract

DEVELOPMENT AND VALIDATION OF ISONIAZID BY USING RPHPLC

D. Sravanthi*, Shaik Haseena

ABSTRACT

Every day many chromatography’s face the need to develop ahigh- performance liquid chromatography (HPLC) method.This review describes the systematic procedures fordeveloping an HPLC method, based on the best informationavailable. HPLC method development involves severalessential steps: sample pretreatment, detection of sample bands,choosing separation conditions, quantitation and methodvalidation. HPLC is an analytical tool which is able to detect,separate and quantify the drug, its various impurities and drugrelated degrades that can form on the synthesis or storage. Italso includes the understanding of chemistry of drug substanceand improves the development of analytical method.Validation is to performed to determine the limits of allowedvariability for the conditions needed to run the method. Thisarticle describes strategies & an issues comes in developmentof a HPLC method development & validation.

Keywords: DL: Detection Limit; QL: Quantitation Limit.