A MASS-SPECTROMETRIC 96-WELL PLATE ASSAY FOR THE DETERMINATION OF MIRABEGRON IN HUMAN PLASMA FOR THE APPLICATION IN PHARMACOKINETIC STUDIES.

2016-10-16T02-20-53Z
Source: Indo American Journal of Pharmaceutical Research
Prashant Kale,*, Y. K. Agrawal.
A purpose was to develop and validate a simple, sensitive, high throughput LC-MS/MS method for quantification of mirabegron in human plasma. Mirabegron is a selective agonist for human beta 3-adrenoceptor. The method involves solid-phase 96 well plate extraction using mirabegron-d5 as an internal standard (ISTD). Chromatographic separation was achieved on Unisol C18 3μ 100Ǻ 4.6 X 100mm column with a mobile phase consist of 0.1% ammonia solution (v/v) and methanol (40:60 v/v) at a flow rate of 1.0mL/min and the total run time was 4.0 min. Detection was carried out through positive electro-spray ionization mode by multiplexing of two product ions. Finally the method was developed with the lower limit of quantification as low as 0.1 ng/ml. The method was validated for linearity, precision, accuracy and stability. All the results were within the pre defined acceptance criteria. The method is ready to use in a pharmacokinetic studies.


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