Determination and validation of pregabalin in bulk and pharmaceutical formulations by reversed phase-high performance liquid chromatography

  • Authors

    • D. N. Vidya Bharathi college of pharmacy
    • R. Chaithra bharathi college of pharmacy
    • G. P. Senthil Kumar bharathi college of pharmacy
    • D. R. Bhadresh bharathi college of pharmacy
  • Pregabalin, Isocratic System, Validation, RP-HPLC, Different Pharmaceutical Formulations.
  • A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Pregabalin in bulk and 5-different pharmaceutical formulations, the separation was accomplished on a C18, 5μm Reverse Phase column (250 mm × 4.6 mm) using a methanol : water (95:5, v/v) mobile phase. The compound was eluted isocratically at a flow rate of 0.8 ml /min. The UV detector was set at 288 nm for the detection of Pregabalin (PRG). The method was linear over the range of 5-45 μg/ml and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization. Robustness testing was also conducted to evaluate the effect of minor changes to the chromatographic system and to establish appropriate system suitability parameters. This method was used successfully for the quality assessment of 5-different pharmaceutical formulations with good precision and accuracy.




  • References

    1. [1] ARMAĞAN Ö. Development and validation of selective spectrophotometric methods for the determination of pregabalin in pharmaceutical preparation. Chinese Journal of Chemistry. 2009 Apr;27(4):781-6.

      [2] Önal A, Sagirli O. Spectrophotometric and spectrofluorimetric methods for the determination of pregabalin in bulk and pharmaceutical preparation. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2009 Feb 1;72(1):68-71.

      [3] Jadhav AS, Pathare DB, Shingare MS. Validated enantioselective LC method, with precolumn derivatization with Marfey’s reagent, for analysis of the antiepileptic drug pregabalin in bulk drug samples. Chromatographia. 2007 Feb 1;65(3-4):253-6.

      [4] Vermeij TA, Edelbroek PM. Simultaneous high-performance liquid chromatographic analysis of pregabalin, gabapentin and vigabatrin in human serum by precolumn derivatization with o-phtaldialdehyde and fluorescence detection. Journal of Chromatography B. 2004 Oct 25;810(2):297-303.

      [5] Walash MI, Belal FF, El-Enany NM, El-Maghrabey MH. Utility of certain nucleophilic aromatic substitution reactions for the assay of pregabalin in capsules. Chemistry Central Journal. 2011 Dec;5(1):36.

      [6] Vaidya VV, Yetal SM, Roy SM, Gomes NA, Joshi SS. LC-MS–MS Determination of pregabalin in human plasma. Chromatographia. 2007 Dec 1;66(11-12):925-8.

      [7] Zhang Y, Holliman C, Tang D, Fast D, Michael S. Development and validation of a direct enantiomeric separation of pregabalin to support isolated perfused rat kidney studies. Journal of Chromatography B. 2008 Nov 1;875(1):148-53.

      [8] Schelkun RM, Yuen PW, Wustrow DJ, Kinsora J, Su TZ, Vartanian MG. Heteroaromatic side-chain analogs of pregabalin. Bioorganic & medicinal chemistry letters. 2006 May 1;16(9):2329-32.

      [9] Mishra AK, Kumar M, Mishra A, Verma A, Chattopadhyay P. Validated UV spectroscopic method for estimation of salbutamol from tablet formulations. Archives of Applied Science Research. 2010;2(3):207-11.

      [10] Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. John Wiley & Sons; 2012 Dec 3.

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  • How to Cite

    N. Vidya, D., Chaithra, R., P. Senthil Kumar, G., & R. Bhadresh, D. (2020). Determination and validation of pregabalin in bulk and pharmaceutical formulations by reversed phase-high performance liquid chromatography. International Journal of Advanced Chemistry, 8(1), 111-117.