کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1223836 967902 2008 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Determination of ranolazine in human plasma by LC–MS/MS and its application in bioequivalence study
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Determination of ranolazine in human plasma by LC–MS/MS and its application in bioequivalence study
چکیده انگلیسی

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 × 4.6 mm, 3 μm) 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 24 h ambient storage, or 1 and 3 months storage at −20 °C. Processed samples (ready for injection) were stable up to 72 h at autosampler (4 °C). The developed method was successfully applied for analyzing ranolazine in plasma samples for a bioequivalence study with 12 healthy volunteers.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 5, 15 December 2008, Pages 1404–1410
نویسندگان
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