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Simultaneous estimation of atorvastatin and its two metabolites from human plasma by ESI‐LC‐MS/MS
Author(s) -
Ghosh Chinmoy,
Jain Ina,
Gaur Shashank,
Patel Niraj,
Upadhyay Anita,
Chakraborty Bhaswat S.
Publication year - 2011
Publication title -
drug testing and analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.065
H-Index - 54
eISSN - 1942-7611
pISSN - 1942-7603
DOI - 10.1002/dta.228
Subject(s) - chromatography , atorvastatin , chemistry , human plasma , bioequivalence , detection limit , extraction (chemistry) , elution , high performance liquid chromatography , calibration curve , analytical chemistry (journal) , pharmacokinetics , pharmacology , medicine
A selective, sensitive, and fast high performance liquid chromatography (HPLC) method with mass spectrometric (MS) detection mode has been developed and validated completely in human plasma. Atorvastatin (ATO), p‐hydroxy atorvastatin (p‐HATO), o‐hydroxy atorvastatin (o‐HATO) and internal standard (IS) are extracted from human plasma via solid phase extraction (SPE) technique. After elution, the solution is evaporated, then reconstituted with 250 µL of Mobile Phase and analyzed using HPLC/MS/MS system. An isocratic mode is used to separate interference peaks using a Symmetry C‐18, 75 × 4.6 mm ID, 3.5 µ, column. The m/z of ATO, o‐HATO and p‐HATO are 559.2/440.2, 575.3/440.4 and 575.0/440.4 respectively. Linearity ranges are 0.05 to 252.92 ng/mL for ATO, p‐HATO and o‐HATO respectively. Calibration functions, lower limit of quantitation (LLOQ), stability, intra‐ and inter‐day reproducibility, accuracy, and recovery are estimated. This method is free from matrix effects and any abnormal ionization. This method was successfully applied to a single dose 80 mg tablet bioequivalence (BE) study of Atorvastatin. Copyright © 2011 John Wiley & Sons, Ltd.