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Simultaneous determination of simvastatin and simvastatin acid in human plasma by LC-MS/MS without polarity switch: application to a bioequivalence study.
J Sep Sci. 2008 Feb; 31(2):301-13.JS

Abstract

A simple, specific and sensitive LC-MS/MS assay for simultaneous determination of simvastatin (SV) and its active beta-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 > or = 0.9987 and 0.9989, respectively. The analytes and IS were extracted from 500 microL aliquots of human plasma via liquid-liquid extraction using methyl tert-butyl ether and separated through an Aquasil C18 column (100 mm x 2.1 mm, 5 microm). 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.

Authors+Show Affiliations

Chemistry Department, School of Sciences, Gujarat University, Navrangpura, Ahmedabad, India.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18196524

Citation

Patel, Bhavin N., et al. "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, vol. 31, no. 2, 2008, pp. 301-13.
Patel BN, Sharma N, Sanyal M, et al. Simultaneous determination of simvastatin and simvastatin acid in human plasma by LC-MS/MS without polarity switch: application to a bioequivalence study. J Sep Sci. 2008;31(2):301-13.
Patel, B. N., Sharma, N., Sanyal, M., & Shrivastav, P. S. (2008). 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, 31(2), 301-13. https://doi.org/10.1002/jssc.200700367
Patel BN, et al. Simultaneous Determination of Simvastatin and Simvastatin Acid in Human Plasma By LC-MS/MS Without Polarity Switch: Application to a Bioequivalence Study. J Sep Sci. 2008;31(2):301-13. PubMed PMID: 18196524.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of simvastatin and simvastatin acid in human plasma by LC-MS/MS without polarity switch: application to a bioequivalence study. AU - Patel,Bhavin N, AU - Sharma,Naveen, AU - Sanyal,Mallika, AU - Shrivastav,Pranav S, PY - 2008/1/16/pubmed PY - 2008/5/6/medline PY - 2008/1/16/entrez SP - 301 EP - 13 JF - Journal of separation science JO - J Sep Sci VL - 31 IS - 2 N2 - A simple, specific and sensitive LC-MS/MS assay for simultaneous determination of simvastatin (SV) and its active beta-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 > or = 0.9987 and 0.9989, respectively. The analytes and IS were extracted from 500 microL aliquots of human plasma via liquid-liquid extraction using methyl tert-butyl ether and separated through an Aquasil C18 column (100 mm x 2.1 mm, 5 microm). 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. SN - 1615-9306 UR - https://www.unboundmedicine.com/medline/citation/18196524/Simultaneous_determination_of_simvastatin_and_simvastatin_acid_in_human_plasma_by_LC_MS/MS_without_polarity_switch:_application_to_a_bioequivalence_study_ DB - PRIME DP - Unbound Medicine ER -