Optimized and Validated RP-HPLC Method for the Determination of Clopidogrel in Bulk and Pharmaceutical Formulation

Authors

  • R. Akter Department of Pharmacy, Noakhali Science and Technology University, Sonapur, Noakhali-3814.
  • S. Banik Lecturer, Department of Pharmacy, Noakhali Science and Technology University, Sonapur, Noakhali-3814. http://orcid.org/0000-0001-9639-6836
  • A. Ghosh Department of Pharmacy, Noakhali Science and Technology University, Sonapur, Noakhali-3814.
  • M. M. O. Rashid Assistant Professor, Department of Pharmacy, Noakhali Science and Technology University, Sonapur, Noakhali-3814.

DOI:

https://doi.org/10.3329/jsr.v8i3.28032

Keywords:

Clopidogrel, RP- HPLC, Accuracy, Precision.

Abstract

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.

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Published

2016-09-01

How to Cite

Akter, R., Banik, S., Ghosh, A., & Rashid, M. M. O. (2016). Optimized and Validated RP-HPLC Method for the Determination of Clopidogrel in Bulk and Pharmaceutical Formulation. Journal of Scientific Research, 8(3), 439–446. https://doi.org/10.3329/jsr.v8i3.28032

Issue

Section

Section B: Chemical and Biological Sciences