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Determination of ranolazine in human plasma by LC-MS/MS and its application in bioequivalence study.
J Pharm Biomed Anal. 2008 Dec 15; 48(5):1404-10.JP

Abstract

A simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for quantification of ranolazine in human plasma. The analytical method consists in the precipitation of plasma sample with methanol, followed by the determination of ranolazine by an LC-MS/MS. The analyte was separated on a Peerless Cyano column (33 mm x 4.6 mm, 3 microm) an isocratic mobile phase of methanol-water containing formic acid (1.0%, v/v) (65:35, v/v) at a flow rate of 1.0 ml/min. Protonated ions formed by a turbo ionspray in positive mode were used to detect analyte and internal standard (IS). The MS/MS detection was made by monitoring the fragmentation of m/z 428.20-->279.50 for ranolazine and m/z 448.30-->285.20 for internal standard on a triple quadrupole mass spectrometer. The method was validated over the concentration range of 5-2000 ng/ml for ranolazine in human plasma with correlation coefficient of 0.9937 (S.D.: +/-0.00367, range: 0.9895-0.9963). The accuracy and precision values obtained from six different sets of quality control samples analyzed in separate occasions ranged from 94.53 to 117.86 and 0.14% to 4.56%, respectively. Mean extraction recovery was 82.36-94.25% for three quality control (QC) samples and 88.37% for IS. Plasma samples were stable for three freeze-thaw cycles, or 24h ambient storage, or 1 and 3 months storage at -20 degrees C. Processed samples (ready for injection) were stable up to 72 h at autosampler (4 degrees C). The developed method was successfully applied for analyzing ranolazine in plasma samples for a bioequivalence study with 12 healthy volunteers.

Authors+Show Affiliations

Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18986788

Citation

Bhaumik, Uttam, et al. "Determination of Ranolazine in Human Plasma By LC-MS/MS and Its Application in Bioequivalence Study." Journal of Pharmaceutical and Biomedical Analysis, vol. 48, no. 5, 2008, pp. 1404-10.
Bhaumik U, Ghosh A, Sarkar AK, et al. Determination of ranolazine in human plasma by LC-MS/MS and its application in bioequivalence study. J Pharm Biomed Anal. 2008;48(5):1404-10.
Bhaumik, U., Ghosh, A., Sarkar, A. K., Bose, A., Selvan, P. S., Sengupta, P., Chakraborty, U. S., Ghosh, D., & Pal, T. K. (2008). Determination of ranolazine in human plasma by LC-MS/MS and its application in bioequivalence study. Journal of Pharmaceutical and Biomedical Analysis, 48(5), 1404-10. https://doi.org/10.1016/j.jpba.2008.09.033
Bhaumik U, et al. Determination of Ranolazine in Human Plasma By LC-MS/MS and Its Application in Bioequivalence Study. J Pharm Biomed Anal. 2008 Dec 15;48(5):1404-10. PubMed PMID: 18986788.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of ranolazine in human plasma by LC-MS/MS and its application in bioequivalence study. AU - Bhaumik,Uttam, AU - Ghosh,Animesh, AU - Sarkar,Amlan Kanti, AU - Bose,Anirbandeep, AU - Selvan,P Senthamil, AU - Sengupta,Pinaki, AU - Chakraborty,Uday Sankar, AU - Ghosh,Debotri, AU - Pal,Tapan Kumar, Y1 - 2008/09/30/ PY - 2008/07/22/received PY - 2008/09/05/revised PY - 2008/09/18/accepted PY - 2008/11/7/pubmed PY - 2009/4/25/medline PY - 2008/11/7/entrez SP - 1404 EP - 10 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 48 IS - 5 N2 - A simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for quantification of ranolazine in human plasma. The analytical method consists in the precipitation of plasma sample with methanol, followed by the determination of ranolazine by an LC-MS/MS. The analyte was separated on a Peerless Cyano column (33 mm x 4.6 mm, 3 microm) an isocratic mobile phase of methanol-water containing formic acid (1.0%, v/v) (65:35, v/v) at a flow rate of 1.0 ml/min. Protonated ions formed by a turbo ionspray in positive mode were used to detect analyte and internal standard (IS). The MS/MS detection was made by monitoring the fragmentation of m/z 428.20-->279.50 for ranolazine and m/z 448.30-->285.20 for internal standard on a triple quadrupole mass spectrometer. The method was validated over the concentration range of 5-2000 ng/ml for ranolazine in human plasma with correlation coefficient of 0.9937 (S.D.: +/-0.00367, range: 0.9895-0.9963). The accuracy and precision values obtained from six different sets of quality control samples analyzed in separate occasions ranged from 94.53 to 117.86 and 0.14% to 4.56%, respectively. Mean extraction recovery was 82.36-94.25% for three quality control (QC) samples and 88.37% for IS. Plasma samples were stable for three freeze-thaw cycles, or 24h ambient storage, or 1 and 3 months storage at -20 degrees C. Processed samples (ready for injection) were stable up to 72 h at autosampler (4 degrees C). The developed method was successfully applied for analyzing ranolazine in plasma samples for a bioequivalence study with 12 healthy volunteers. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/18986788/Determination_of_ranolazine_in_human_plasma_by_LC_MS/MS_and_its_application_in_bioequivalence_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(08)00514-1 DB - PRIME DP - Unbound Medicine ER -