Home  About us  Contact
 

Simvastatin Acid (simvastatin + acid)

Distribution by Scientific Domains
Chemistry100%

Selected Abstracts

Simultaneous determination of simvastatin and simvastatin acid in human plasma by LC-MS/MS without polarity switch: Application to a bioequivalence study

JOURNAL OF SEPARATION SCIENCE, JSS, Issue 2 2008
Bhavin N. Patel
Abstract A simple, specific and sensitive LC-MS/MS assay for simultaneous determination of simvastatin (SV) and its active ,-hydroxy acid metabolite, simvastatin acid (SVA) in human plasma was developed using a statin analog as internal standard (IS). The method was validated over a dynamic linear range of 0.20,100.00 ng/mL for SV and 0.10,50.00 ng/mL for SVA with correlation coefficient r , 0.9987 and 0.9989, respectively. The analytes and IS were extracted from 500 ,L aliquots of human plasma via liquid-liquid extraction using methyl tert -butyl ether and separated through an Aquasil C18 column (100 mm×2.1 mm, 5 ,m). Detection of analytes and IS was done by MS/MS with a turbo ion spray interface operating in positive ion and selective reaction monitoring acquisition mode. The total chromatographic run time was 3.0 min. Flash freezing of the aqueous phase was an added advantage during liquid-liquid extraction, which considerably reduced time and labour. The method was extensively validated for its accuracy, precision, recovery, stability studies and matrix effect. The method was successfully used for bioequivalence study of 40 mg SV tablet formulation in 12 human subjects under fasting condition. [source]

Development and validation of a highly sensitive and robust LC-ESI-MS/MS method for simultaneous quantitation of simvastatin acid, amlodipine and valsartan in human plasma: application to a clinical pharmacokinetic study,

BIOMEDICAL CHROMATOGRAPHY, Issue 6 2009
Addepalli V. Ramani
Abstract A high-throughput, simple, highly sensitive and specific LC-MS/MS method has been developed for simultaneous estimation of simvastatin acid (SA), amlodipine (AD) and valsartan (VS) with 500 µL of human plasma using deuterated simvastatin acid as an internal standard (IS). The API-4000 LC-MS/MS was operated under the multiple reaction-monitoring mode (MRM) using electrospray ionization. The assay procedure involved precipitation of SA, AD, VS and IS from plasma with acetonitrile. The total run time was 2.8 min and the elution of SA, AD, VS and IS occurred at 1.81, 1.12, 1.14 and 1.81 min, respectively; this was achieved with a mobile phase consisting of 0.02 m ammonium formate (pH 4.5):acetonitrile (20:80, v/v) at a flow rate of 0.50 mL/min on an X-Terra C18 column. A linear response function was established for the range of concentrations 0.5,50 ng/mL (r > 0.994) for VS and 0.2,50 ng/mL (r > 0.996) for SA and AD. The method validation parameters for all three analytes met the acceptance as per FDA guidelines. This novel method has been applied to human pharmacokinetic study. Copyright © 2009 John Wiley & Sons, Ltd. [source]