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Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood.
J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Apr 13; 834(1-2):149-54.JC

Abstract

A highly precise and sensitive method for the estimation of indapamide in human whole blood using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) is described. The method developed is validated in human whole-blood matrix, with a sensitivity of 0.5 ng/ml as lower limit of quantification. The procedure for the extraction of indapamide and glimepiride as internal standard (IS) involves haemolysis and deprotienation of whole blood using ZnSO(4) followed by liquid-liquid extraction using ethyl acetate. The sample extracts after drying were reconstituted and analysed by LC-MS/MS, equipped with turbo ion spray (TIS) source, operating in the positive ion and selective reaction monitoring (SRM) acquisition mode to quantify indapamide in human whole blood. The mean recovery for indapamide was 82.40 and 93.23% for IS. The total run time was 2.5 min to monitor both indapamide and the IS. The response of the LC-MS/MS method for indapamide was linear over the range of 0.5-80.0 ng/ml with correlation coefficient, r>or=0.9991. The coefficient of variance (% CV) at 0.5 ng/ml was 4.02% and the accuracy was well within the accepted limit of +/-20% at 0.5 ng/ml and +/-15% at all other concentrations in the linear range. This method is fully validated for the accuracy, precision and stability studies and also applied to subject-sample analysis of bioequivalence study for 1.5mg sustained-release (SR) formulations.

Authors+Show Affiliations

Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

16531130

Citation

Jain, Deepak S., et al. "Liquid Chromatography-tandem Mass Spectrometry Validated Method for the Estimation of Indapamide in Human Whole Blood." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 834, no. 1-2, 2006, pp. 149-54.
Jain DS, Subbaiah G, Sanyal M, et al. Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood. J Chromatogr B Analyt Technol Biomed Life Sci. 2006;834(1-2):149-54.
Jain, D. S., Subbaiah, G., Sanyal, M., Pande, U. C., & Shrivastav, P. (2006). Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 834(1-2), 149-54.
Jain DS, et al. Liquid Chromatography-tandem Mass Spectrometry Validated Method for the Estimation of Indapamide in Human Whole Blood. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Apr 13;834(1-2):149-54. PubMed PMID: 16531130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood. AU - Jain,Deepak S, AU - Subbaiah,Gunta, AU - Sanyal,Mallika, AU - Pande,U C, AU - Shrivastav,Pranav, Y1 - 2006/03/10/ PY - 2005/10/14/received PY - 2006/01/20/revised PY - 2006/02/21/accepted PY - 2006/3/15/pubmed PY - 2006/6/29/medline PY - 2006/3/15/entrez SP - 149 EP - 54 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 834 IS - 1-2 N2 - A highly precise and sensitive method for the estimation of indapamide in human whole blood using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) is described. The method developed is validated in human whole-blood matrix, with a sensitivity of 0.5 ng/ml as lower limit of quantification. The procedure for the extraction of indapamide and glimepiride as internal standard (IS) involves haemolysis and deprotienation of whole blood using ZnSO(4) followed by liquid-liquid extraction using ethyl acetate. The sample extracts after drying were reconstituted and analysed by LC-MS/MS, equipped with turbo ion spray (TIS) source, operating in the positive ion and selective reaction monitoring (SRM) acquisition mode to quantify indapamide in human whole blood. The mean recovery for indapamide was 82.40 and 93.23% for IS. The total run time was 2.5 min to monitor both indapamide and the IS. The response of the LC-MS/MS method for indapamide was linear over the range of 0.5-80.0 ng/ml with correlation coefficient, r>or=0.9991. The coefficient of variance (% CV) at 0.5 ng/ml was 4.02% and the accuracy was well within the accepted limit of +/-20% at 0.5 ng/ml and +/-15% at all other concentrations in the linear range. This method is fully validated for the accuracy, precision and stability studies and also applied to subject-sample analysis of bioequivalence study for 1.5mg sustained-release (SR) formulations. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/16531130/Liquid_chromatography_tandem_mass_spectrometry_validated_method_for_the_estimation_of_indapamide_in_human_whole_blood_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(06)00149-8 DB - PRIME DP - Unbound Medicine ER -