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First LC-MS/MS electrospray ionization validated method for the quantification of perindopril and its metabolite perindoprilat in human plasma and its application to bioequivalence study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Jun 06; 837(1-2):92-100.JC

Abstract

A high throughput bioanalytical method based on solid phase extraction and liquid chromatography-tandem mass spectrometry (LC-MS/MS), has been developed for the estimation of perindopril and its metabolite perindoprilat, an angiotensin-converting enzyme inhibitor in human plasma. Ramipril was used as internal standard (IS). The extraction of perindopril, perindoprilat and ramipril from the plasma involved treatment with phosphoric acid followed by solid phase extraction (SPE) using hydrophilic lipophilic balance HLB cartridge. The SPE eluate without drying were analyzed by LC-MS/MS, equipped with turbo ion spray (TIS) source, operating in the negative ion and selective reaction monitoring (SRM) acquisition mode to quantify perindopril and perindoprilat in human plasma. The total chromatographic run time was 1.5 min with retention time for perindopril, perindoprilat and ramipril at 0.33, 0.35 and 0.30 min. The developed method was validated in human plasma matrix, with a sensitivity of 0.5 ng/ml (CV, 7.67%) for perindopril and 0.3 ng/ml (CV, 4.94%) for perindoprilat. This method was extensively validated for its accuracy, precision, recovery, stability studies and matrix effect especially because the pattern of elution of all the analytes appears as flow injection elution. Sample preparation by this method yielded extremely clean extracts with very good and consistent mean recoveries; 78.29% for perindopril, 76.32% for perindoprilat and 77.72% for IS. The response of the LC-MS/MS method for perindopril and perindoprilat was linear over the range 0.5-350.0 ng/ml for perindopril and 0.3-40 ng/ml for perindoprilat with correlation coefficient, r>/=0.9998 and 0.9996, respectively. The method was successfully applied for bioequivalence studies in human subjects samples with 4 mg immediate release (IR) formulations.

Authors+Show Affiliations

Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380 009, 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

16709467

Citation

Jain, Deepak S., et al. "First LC-MS/MS Electrospray Ionization Validated Method for the Quantification of Perindopril and Its Metabolite Perindoprilat in Human Plasma and Its Application to Bioequivalence Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 837, no. 1-2, 2006, pp. 92-100.
Jain DS, Subbaiah G, Sanyal M, et al. First LC-MS/MS electrospray ionization validated method for the quantification of perindopril and its metabolite perindoprilat in human plasma and its application to bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2006;837(1-2):92-100.
Jain, D. S., Subbaiah, G., Sanyal, M., Pande, U. C., & Shrivastav, P. (2006). First LC-MS/MS electrospray ionization validated method for the quantification of perindopril and its metabolite perindoprilat in human plasma and its application to bioequivalence study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 837(1-2), 92-100.
Jain DS, et al. First LC-MS/MS Electrospray Ionization Validated Method for the Quantification of Perindopril and Its Metabolite Perindoprilat in Human Plasma and Its Application to Bioequivalence Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Jun 6;837(1-2):92-100. PubMed PMID: 16709467.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - First LC-MS/MS electrospray ionization validated method for the quantification of perindopril and its metabolite perindoprilat in human plasma and its application to bioequivalence study. AU - Jain,Deepak S, AU - Subbaiah,Gunta, AU - Sanyal,Mallika, AU - Pande,Umesh C, AU - Shrivastav,Pranav, Y1 - 2006/05/18/ PY - 2006/01/24/received PY - 2006/04/03/revised PY - 2006/04/05/accepted PY - 2006/5/20/pubmed PY - 2006/8/29/medline PY - 2006/5/20/entrez SP - 92 EP - 100 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 837 IS - 1-2 N2 - A high throughput bioanalytical method based on solid phase extraction and liquid chromatography-tandem mass spectrometry (LC-MS/MS), has been developed for the estimation of perindopril and its metabolite perindoprilat, an angiotensin-converting enzyme inhibitor in human plasma. Ramipril was used as internal standard (IS). The extraction of perindopril, perindoprilat and ramipril from the plasma involved treatment with phosphoric acid followed by solid phase extraction (SPE) using hydrophilic lipophilic balance HLB cartridge. The SPE eluate without drying were analyzed by LC-MS/MS, equipped with turbo ion spray (TIS) source, operating in the negative ion and selective reaction monitoring (SRM) acquisition mode to quantify perindopril and perindoprilat in human plasma. The total chromatographic run time was 1.5 min with retention time for perindopril, perindoprilat and ramipril at 0.33, 0.35 and 0.30 min. The developed method was validated in human plasma matrix, with a sensitivity of 0.5 ng/ml (CV, 7.67%) for perindopril and 0.3 ng/ml (CV, 4.94%) for perindoprilat. This method was extensively validated for its accuracy, precision, recovery, stability studies and matrix effect especially because the pattern of elution of all the analytes appears as flow injection elution. Sample preparation by this method yielded extremely clean extracts with very good and consistent mean recoveries; 78.29% for perindopril, 76.32% for perindoprilat and 77.72% for IS. The response of the LC-MS/MS method for perindopril and perindoprilat was linear over the range 0.5-350.0 ng/ml for perindopril and 0.3-40 ng/ml for perindoprilat with correlation coefficient, r>/=0.9998 and 0.9996, respectively. The method was successfully applied for bioequivalence studies in human subjects samples with 4 mg immediate release (IR) formulations. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/16709467/First_LC_MS/MS_electrospray_ionization_validated_method_for_the_quantification_of_perindopril_and_its_metabolite_perindoprilat_in_human_plasma_and_its_application_to_bioequivalence_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(06)00319-9 DB - PRIME DP - Unbound Medicine ER -