Validated extractive analytical methods for the estimation of pregabalin in bulk and pharmaceutical dosage form

  • Authors

    • PoojaShree. P bharathi college of pharmacy
    • Senthil kumar G P Bharathi College of Pharmacy
    • Chaithra R Bharathi College of Pharmacy
    • Vidya D N Bharathi College of Pharmacy
    • Bhadresh D R Bharathi College of Pharmacy
    • Manojkumar S Bharathi College of Pharmacy
    2020-02-19
    https://doi.org/10.14419/ijac.v8i1.30273
  • Bromocresol Green (BCG), Bromocresol Purple (BCP), Ion-Pair Complex, Pregabalin, Spectrophotometric.

  • Abstract

    Two simple, rapid, sensitive and accurate spectrophotometric methods are described for the determination of Pregabalin (PRG) in bulk and pharmaceutical formulations. The methods are based on the reactions of the drug with bromocresol purple (BCP) and bromocresol green (BCG) in buffered hydrochloric acid solutions at pH 1.2 to give coloured ion-pair complexes extractable with chloroform. The coloured products are quantitated spectrophotometrically at 431 nm with BCP and 444.80 nm with BCG. Beer's law is obeyed in the concentration range 10-50 µg/ml with both reagents. Recovery studies gave satisfactory results indicating that none of common additives and excipients interfere the assay method. The proposed methods are found to be simple, accurate and reproducible that was successfully applied for the analysis of capsule formulations. The developed methods are easy to use, accurate and highly cost-effective for routine studies relative to HPLC and other techniques.

     

     

     

  • 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. https://doi.org/10.1002/cjoc.200990130.

      [2] Onal 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. https://doi.org/10.1016/j.saa.2008.08.009.

      [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. https://doi.org/10.1365/s10337-006-0152-z.

      [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. https://doi.org/10.1016/S1570-0232(04)00662-2.

      [5] Mandal U., Sarkar K.A., Gowda K.V., Agarwal S., Bose A., Bhaumik U., Ghosh D., Pal T.K., Journal of Chromatographia, 67(3-4), (2008) 237-243. https://doi.org/10.1365/s10337-007-0440-2.

      [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. https://doi.org/10.1365/s10337-007-0430-4.

      [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. https://doi.org/10.1016/j.jchromb.2008.07.042.

      [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. https://doi.org/10.1016/j.bmcl.2005.06.090.

      [9] Indian Pharmacopoeia, CBS publishers, II volume, 1996, A-144-5.

      [10] Internationl Conference on Harmonized, guideline on validation procedure, definition terminology federal register. 1995, 60:11260.

      [11] The United States of Pharmacopoeia (USP 24), Asian edition, published by the United States Pharmacopeial convention, Inc USA 2000.

      [12] P.D.Sethi “HPLC quantitative analysis of pharmaceutical formulations†Third edition, CBS Publications, India, 2001; 53-64.

      [13] Lloyd R. Snyder, Joseph L. Glajch, “Practical HPLC method Development†second edition, Wiley Interscience, New York, 685-712.

      [14] Adlin J.N., Jose G.B., Tamizhmani T., Validative extractive spectrophotometric estimation of Nicorandil in tablet dosage form. Indian Drugs, 45 (7), 2008, 581-583.

      [15] Patel J.M., Talele G.S., Fursule R.A., Surana S.J., Extractive Spectrophotometric determination of Desloratidine from its bulk and pharmaceutical dosage form. Indian Drugs, 43(6), (2006), 507-509.

      [16] Gurupadayya B.M., Vijaya B.V., Manohara Y.N., Prasad R.D.V., Heamalatha S., Spectrophotometric methods for the estimation of Amrinone Lactate in Bulk and Pharmaceutical Formulation. Indian Drugs, 45 (3), (2008), 193-198.

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  • How to Cite

    P, P., kumar G P, S., R, C., D N, V., D R, B., & S, M. (2020). Validated extractive analytical methods for the estimation of pregabalin in bulk and pharmaceutical dosage form. International Journal of Advanced Chemistry, 8(1), 22-26. https://doi.org/10.14419/ijac.v8i1.30273

    Received date: 2019-12-31

    Accepted date: 2020-02-12

    Published date: 2020-02-19