Development and Validation of Analytical Methods for Multicomponent Formulations

Abstract

The present thesis is entitled as Development and Validation of Analytical Methods for Multicomponent Formulations . Drug analysis is very essential step to evaluate drug efficacy and toxicity. Both Efficacy and toxicity are directly associated with drug newlineconcentration present in formulation. If concentration of drug in formulation is more than newlinemention it may be toxic to our health and if concentration of drug is present less than newlinemention, then drug preparation may not be effective. newlineAnalytical method development and validation is one of the research areas in the field of newlinedrug analysis, used in identification and determination of the drug concentration in bulk newlinesamples, pharmaceutical formulation and in biological matrixes like blood, plasma, urine newlineetc. newlineGenerally two types of formulation are available in market, single and multicomponent newlineformulations. Multicomponent formulations are those formulations which contain two or newlinemore drugs. In present time, various pharmaceutical companies are focusing on newlinemulticomponent formulations for greater efficacy and safety. Analysis of multi newlinecomponent formulations and mixtures by any single analytical method is a very newlinechallenging task. Hence there is always a necessity of developing new, economic newlinecompetent methods for analysis of marketed formulations. Validation must be performed newlineafter development of an analytical method as per the standard guidelines. newlineToday H. pylori are one of the common bacterial infections in the world. Upper gastro newlineintestinal tract is primarily affected with this bacterial infection. H. pylori are primarily newlineresponsible for various types of ulcer like dyspepsia, gastric and duodenal ulcers. As per newlineliterature survey, it had been concluded that various triple and quadruple regimens were newlineusing in H. pylori therapy like obliteration therapy and rescue therapy but fails in newlineapproximately 20% of cases. newlineLiterature survey suggested that there one more triple drug regimen of omeprazole, newlineamoxicillin and rifabutin is under clinical trial for H. pylori therapy