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Electrospray ionization LC-MS/MS validated method to quantify griseofulvin in human plasma and its application to bioequivalence study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 May 01; 850(1-2):318-26.JC

Abstract

A simple, sensitive and rapid liquid chromatography/tandem mass spectrometry (LC-MS/MS) method has been developed and validated to quantify griseofulvin in human plasma using propranolol hydrochloride as internal standard (IS). Samples were prepared using solid phase extraction and analysed without drying and reconstitution. The analytes were chromatographed on Hypersil, hypurity C18 reverse phase column under isocratic conditions using 0.05% formic acid in water:acetonitrile (30:70, v/v) as the mobile phase. Total chromatographic run time was 3.0 min. Quantitation was done on a triple quadrupole mass analyzer API-3000, equipped with turbo ion spray interface and operating in multiple reaction monitoring (MRM) mode to detect parent-->product ion transition for analyte and IS. The method was validated for sensitivity, matrix effect, accuracy and precision, linearity, recovery and stability studies. Linearity in plasma was observed over the concentration range 20-3000 ng/mL for griseofulvin. Lower limit of quantification (LLOQ) achieved was 20 ng/mL with precision (CV) less than 10% using 5 microL injection volume. The absolute recovery of analyte (87.36%) and IS (98.91%) from spiked plasma samples was consistent and reproducible. Inter-batch and intra-batch coefficients of variation across four validation runs (LLOQ, LQC, MQC and HQC) was less than 7.5%. The accuracy determined at these levels was within +/-4.2% in terms of relative error. The method was applied to a pilot bioequivalence study of 500 mg griseofulvin tablet in six healthy human subjects under fed condition.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

17196449

Citation

Mistri, Hiren N., et al. "Electrospray Ionization LC-MS/MS Validated Method to Quantify Griseofulvin in Human Plasma and Its Application to Bioequivalence Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 850, no. 1-2, 2007, pp. 318-26.
Mistri HN, Jangid AG, Sanyal M, et al. Electrospray ionization LC-MS/MS validated method to quantify griseofulvin in human plasma and its application to bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;850(1-2):318-26.
Mistri, H. N., Jangid, A. G., Sanyal, M., & Shrivastav, P. (2007). Electrospray ionization LC-MS/MS validated method to quantify griseofulvin in human plasma and its application to bioequivalence study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 850(1-2), 318-26.
Mistri HN, et al. Electrospray Ionization LC-MS/MS Validated Method to Quantify Griseofulvin in Human Plasma and Its Application to Bioequivalence Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 May 1;850(1-2):318-26. PubMed PMID: 17196449.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Electrospray ionization LC-MS/MS validated method to quantify griseofulvin in human plasma and its application to bioequivalence study. AU - Mistri,Hiren N, AU - Jangid,Arvind G, AU - Sanyal,Mallika, AU - Shrivastav,Pranav, Y1 - 2006/12/28/ PY - 2006/10/03/received PY - 2006/11/28/revised PY - 2006/12/01/accepted PY - 2007/1/2/pubmed PY - 2007/7/25/medline PY - 2007/1/2/entrez SP - 318 EP - 26 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 850 IS - 1-2 N2 - A simple, sensitive and rapid liquid chromatography/tandem mass spectrometry (LC-MS/MS) method has been developed and validated to quantify griseofulvin in human plasma using propranolol hydrochloride as internal standard (IS). Samples were prepared using solid phase extraction and analysed without drying and reconstitution. The analytes were chromatographed on Hypersil, hypurity C18 reverse phase column under isocratic conditions using 0.05% formic acid in water:acetonitrile (30:70, v/v) as the mobile phase. Total chromatographic run time was 3.0 min. Quantitation was done on a triple quadrupole mass analyzer API-3000, equipped with turbo ion spray interface and operating in multiple reaction monitoring (MRM) mode to detect parent-->product ion transition for analyte and IS. The method was validated for sensitivity, matrix effect, accuracy and precision, linearity, recovery and stability studies. Linearity in plasma was observed over the concentration range 20-3000 ng/mL for griseofulvin. Lower limit of quantification (LLOQ) achieved was 20 ng/mL with precision (CV) less than 10% using 5 microL injection volume. The absolute recovery of analyte (87.36%) and IS (98.91%) from spiked plasma samples was consistent and reproducible. Inter-batch and intra-batch coefficients of variation across four validation runs (LLOQ, LQC, MQC and HQC) was less than 7.5%. The accuracy determined at these levels was within +/-4.2% in terms of relative error. The method was applied to a pilot bioequivalence study of 500 mg griseofulvin tablet in six healthy human subjects under fed condition. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/17196449/Electrospray_ionization_LC_MS/MS_validated_method_to_quantify_griseofulvin_in_human_plasma_and_its_application_to_bioequivalence_study_ DB - PRIME DP - Unbound Medicine ER -