Development and validation of analytical methods for quantification of new drug molecules 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 , pharmaceutical dosage forms and in biological fluids like blood serum, urine etc in view of the industrial scenario and literature, by using spectral and chromatographic techniques, revealed the utility of analytical instruments like HPLC, HPTLC and LC MS for the quantification of API s at greater accuracy and precision in quantification of drugs in formulation and in biological fluids even at low concentration. newlineDetermination of Active medicament in terms of purity is essential in the department of quality control and quality assurance for the pharmaceutical dosage form, prior to its entry into market. Now days, potency of the drugs and efficacy are playing major role in patient compliance during therapy. Hence, No matter the therapeutic agent present as individual or in the combination with other drugs, the amount of active ingredient at individual dose should be complied as per posology direction in order to achieve efficacy. However, in recent decades there are lot of analytical methods have been established for the determination of medicament in quality control and quality assurance aspects. 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 plays a vital role in newlineFDA approval of newer potent drugs with respect to method development, validation and determination of drugs. newlineThe main goal of this research work is selected based on the increasing needs of the pharmaceutical industry in developing suitable analytical methods. Among the various other available techniques the aim and objective of this work was focused on the modern chromatographic techniques such as HPLC-MS/MS which are accurate precise, sophisticated and are having wid