Development and validation of analytical methods for new chemical entities and their dosage forms by using high performance liquid chromatography

Abstract

Analytical method development and validation is a good research in the field of Pharmaceutical analysis, utilized to determine the drug content in bulk and pharmaceutical dosage forms and in biological fluids like blood, serum, urine etc. In view of the industrial scenario and literature, it was noted that chromatographic techniques like HPLC, LC MS/MS methods have created revolutionary precision and accuracy in quantification of drugs in Formulation and in Biological fluids even at low concentration. newlineThere is a rapid advancement and developments in the field of pharmaceutical analysis where sensitive chromatographic and spectral techniques have been evoked for the determination of drugs in pharmaceutical dosage forms and in biological fluids. In pharmaceutical industry, the analyst or bioanalyst plays an important role in FDA approval of newer potent drugs with respect to validation and determination of drugs. newlineThe main goal of this research activity is selected based on the increasing needs of the pharmaceutical/biopharmaceutical industry in developing suitable analytical methods. Among the various other available techniques, the scope of this work was focused on the modern chromatographic techniques such as LC-MS/MS which are accurate, precise, sophisticated and are having wide spectrum of application in pharmaceutical/biopharmaceutical industries. newlinePharmacokinetic and bioequivalence studies require very precise and accurate assay methods that are well validated to quantify drugs in biological samples. The assay methods have to be sensitive enough to determine the biological sample concentration of the drug and/or its metabolite(s) for a period of about five elimination half- life s after dosage of the drug. The assay methods also have to be very selective to ensure reliable data, free from interference of endogenous compounds and possible metabolites in the biological samples. newlineBioanalytical methods have to be simple, sensitive, selective, rugged and reproducible for long run analysis in BA/BE studies. The Valid