Analytical Method Development and Validation of Amlodipine in Human Plasma by using Lc-Ms/Ms

Akiful Haque M; Shanthi Priya DK; Bakshi V

Abstract

Analytical Method Development and Validation of Amlodipine in Human Plasma by using Lc-Ms/Ms

Author(s): Akiful Haque M, Shanthi Priya DK, Bakshi V

A touchy and precise excessive-overall performance liquid chromatography combined with triple quadrupole mass spectrometry (lc-ms/ms) method, working in the positive ionization mode, for quantifying of Amlodipine in human plasma using Amlodipine maleate d4 as inner widespread (IS) was advanced and confirmed. The analyte and internal standard were extracted by using solid-section extraction with a aggregate of 5 mm ammonium acetate in 0.1% formic acid: methanol: acetonitrile (40: 30: 30%). The Chromatographic separation was performed on zorbax sb, c18, 50*4.6 mm, 3.5 mm. The analytical approach is legitimate for the estimation of amlodipine, in human plasma over a number 0.100 ng/ml to 9.990 ng/ml with the detection of amlodipine m/z-409.10 (determine) and 238.00 (product) and internal standard amlodipine maleate d4 m/z-413.20 (determine) and 238.00 (product) in positive ion mode. The results of carryover test, matrix impact, linearity, precision and accuracy, stabilities, dilution integrity, run size assessment check provided in this document are inside the popularity range. The robust and rapid lc-ms/ms approach has been efficaciously carried out for ordinary assay to aid bioequivalence or pharmacokinetics studies of amlodipine administered as oral dose to wholesome volunteers.

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