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  • 标题:Optimized and Validated RP-HPLC Method for the Determination of Clopidogrel in Bulk and Pharmaceutical Formulation
  • 本地全文:下载
  • 作者:R. Akter ; S. Banik ; A. Ghosh
  • 期刊名称:Journal of Scientific Research
  • 印刷版ISSN:2070-0237
  • 电子版ISSN:2070-0245
  • 出版年度:2016
  • 卷号:8
  • 期号:3
  • 页码:439-446
  • DOI:10.3329/jsr.v8i3.28032
  • 语种:English
  • 出版社:Rajshahi University
  • 摘要:This study was undertaken to develop a novel, simple, rapid, accurate and precise sensitive reverse phase HPLC method for estimating Clopidogrel in bulk and pharmaceutical dosage form. The current method in this study was achieved by Thermo Hypersil RP C-18 column (100 mm x 4.6 mm, 3.5 µm) using a mobile phase of Phosphate Buffer: Acetonitrile (pH 3.0) is 70: 30 at a column temperature of 25°C. The effluent was monitored by UV detector at 238 nm. The retention time of Clopidogrel was 4.75 min with a flow rate 1.0 mL/min. Calibration curve was linear in the range of 10-60 µg/mL. The method was validated for linearity, precision, robustness and accuracy as per ICH guidelines. The results of all the validation parameters were well within their acceptance values (%RSD <2.0 specified by the USP, ICH and FDA), which prove applicability of the proposed method for routine analyses and quality-control assay of Clopidogrel in pharmaceutical preparations.
  • 其他摘要:This study was undertaken to develop a novel, simple, rapid, accurate and precise sensitive reverse phase HPLC method for estimating Clopidogrel in bulk and pharmaceutical dosage form. The current method in this study was achieved by Thermo Hypersil RP C-18 column (100 mm x 4.6 mm, 3.5 µm) using a mobile phase of Phosphate Buffer: Acetonitrile (pH 3.0) is 70: 30 at a column temperature of 25°C. The effluent was monitored by UV detector at 238 nm. The retention time of Clopidogrel was 4.75 min with a flow rate 1.0 mL/min. Calibration curve was linear in the range of 10-60 µg/mL. The method was validated for linearity, precision, robustness and accuracy as per ICH guidelines. The results of all the validation parameters were well within their acceptance values (%RSD <2.0 specified by the USP, ICH and FDA), which prove applicability of the proposed method for routine analyses and quality-control assay of Clopidogrel in pharmaceutical preparations.
  • 关键词:Clopidogrel; RP- HPLC;Accuracy;Precision.
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