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Bioanalytical Method Development and Validation by Hyphenated Technique (LC-MS/MS)

Asif Husain* , Farah Iram* , Huma Iram* , Mohd Arif* , A.A. Siddiqui* , Asif Husain*

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Journal of Pharmaceutical and Medicinal Chemistry 2(1):p 11-26, January - June 2016. | DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.2116.2

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Abstract

 Bioanalytical method development plays importance role in the preclinical and clinical studies. Pharmacokinetics of any drug and/or its metabolite can be recognised by bioanalytical studies. The quantitative analysis of drugs and their metabolites in the biological media is done by bioanalytical studies. Physico-chemical and biological techniques are used for these studies. Each bioanalytical method should be selective, sensitive and reliable for the quantitative evaluation in drug discovery process. Bioanalytical method development consists of sample preparation, chromatographic separation and detection by using proper analytical method. Each developed method should be validated as per the regulatory authorities, so as to give reliable and reproducible method for the intended use. Many analytical techniques can be use for bioanlysis, LCMS/MS is one of them. In Liquid chromatographymass spectrometry (LC- S/MS) the separation of analyte is done by LC and detection is carried out by MS. LC-MS/MS prominently used in evaluation and interpretation of bioavailability, bioequivalence and pharmacokinetic data. This review also focused on various validation parameters such as: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery stability, etc.

Keywords: Bioanalytical; Liquid Chromatography; Spectrometry; Bioanalysis; Validation.

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DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.2116.2

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