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Development and validation of a high throughput and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of diltiazem and its two metabolites in human plasma: Application to a bioequivalence study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Mar 15; 877(8-9):791-8.JC

Abstract

A high throughput and specific method using ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) was developed for the simultaneous determination of diltiazem and its two metabolite (N-desmethyldiltiazem and O-desacetyldiltiazem) in human plasma. A one-step liquid-liquid extraction (LLE) with methyl-t-butyl ether (MTBE) involved for the extraction of diltiazem (DLTZ), metabolites (DMeD and DAcD) and internal standard. Analytes were chromatographed on a ACQUITY UPLC BEH C(18) column (100 mm x 2.1 mm, i.d., 1.7 microm) with isocratic elution at a flow rate of 0.2 mL/min using 10 mM ammonium acetate buffer-acetonitrile (25:75, v/v). The Quattro Premier XE LC-MS/MS was operated under the multiple reaction-monitoring mode (MRM) using the electrospray ionization technique. Using 300 microL plasma, the method was validated over the concentration range 0.48-639.9 ng/mL for DLTZ and 0.24-320.1 for DMeD and 0.24-320.7 ng/mL for DAcD, with a lower limit of quantification of 0.48 ng/mL for DLTZ and 0.24 ng/mL for metabolites. The intra- and inter-day precision and accuracy were within 10.0%. The recovery was 77.4%, 76.0%, 74.5% and 74.1% for DLTZ, DMeD, DAcD and Ziprasidone, respectively. Total run time was 2.0 min only.

Authors+Show Affiliations

Department of Chemistry, Pilvai Science College, Pilvai, Vijapur, Gujarat State, India.No affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Validation Study

Language

eng

PubMed ID

19237322

Citation

Dasandi, Bhavesh, et al. "Development and Validation of a High Throughput and Robust LC-MS/MS With Electrospray Ionization Method for Simultaneous Quantitation of Diltiazem and Its Two Metabolites in Human Plasma: Application to a Bioequivalence Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 877, no. 8-9, 2009, pp. 791-8.
Dasandi B, Shah S, Shivprakash . Development and validation of a high throughput and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of diltiazem and its two metabolites in human plasma: Application to a bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2009;877(8-9):791-8.
Dasandi, B., Shah, S., & Shivprakash, . (2009). Development and validation of a high throughput and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of diltiazem and its two metabolites in human plasma: Application to a bioequivalence study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 877(8-9), 791-8. https://doi.org/10.1016/j.jchromb.2009.02.016
Dasandi B, Shah S, Shivprakash . Development and Validation of a High Throughput and Robust LC-MS/MS With Electrospray Ionization Method for Simultaneous Quantitation of Diltiazem and Its Two Metabolites in Human Plasma: Application to a Bioequivalence Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Mar 15;877(8-9):791-8. PubMed PMID: 19237322.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a high throughput and robust LC-MS/MS with electrospray ionization method for simultaneous quantitation of diltiazem and its two metabolites in human plasma: Application to a bioequivalence study. AU - Dasandi,Bhavesh, AU - Shah,Sanjay, AU - Shivprakash,, Y1 - 2009/02/11/ PY - 2008/09/08/received PY - 2009/01/29/revised PY - 2009/02/05/accepted PY - 2009/2/25/entrez PY - 2009/2/25/pubmed PY - 2009/4/8/medline SP - 791 EP - 8 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 877 IS - 8-9 N2 - A high throughput and specific method using ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) was developed for the simultaneous determination of diltiazem and its two metabolite (N-desmethyldiltiazem and O-desacetyldiltiazem) in human plasma. A one-step liquid-liquid extraction (LLE) with methyl-t-butyl ether (MTBE) involved for the extraction of diltiazem (DLTZ), metabolites (DMeD and DAcD) and internal standard. Analytes were chromatographed on a ACQUITY UPLC BEH C(18) column (100 mm x 2.1 mm, i.d., 1.7 microm) with isocratic elution at a flow rate of 0.2 mL/min using 10 mM ammonium acetate buffer-acetonitrile (25:75, v/v). The Quattro Premier XE LC-MS/MS was operated under the multiple reaction-monitoring mode (MRM) using the electrospray ionization technique. Using 300 microL plasma, the method was validated over the concentration range 0.48-639.9 ng/mL for DLTZ and 0.24-320.1 for DMeD and 0.24-320.7 ng/mL for DAcD, with a lower limit of quantification of 0.48 ng/mL for DLTZ and 0.24 ng/mL for metabolites. The intra- and inter-day precision and accuracy were within 10.0%. The recovery was 77.4%, 76.0%, 74.5% and 74.1% for DLTZ, DMeD, DAcD and Ziprasidone, respectively. Total run time was 2.0 min only. SN - 1873-376X UR - https://www.unboundmedicine.com/medline/citation/19237322/Development_and_validation_of_a_high_throughput_and_robust_LC_MS/MS_with_electrospray_ionization_method_for_simultaneous_quantitation_of_diltiazem_and_its_two_metabolites_in_human_plasma:_Application_to_a_bioequivalence_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(09)00098-1 DB - PRIME DP - Unbound Medicine ER -