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Validated spectrophotometric method for quantitative determination of simvastatin in pharmaceutical formulations and human serum

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Abstract

A simple ultraviolet spectrophotometric method for the determination of simvastatin in methanol has been devised and compared with the existing pharmacopoeial RP-HPLC method for the estimation of the drug. Analytical parameters such as stability, selectivity, accuracy, and precision have been established for the method, using SIMS® tablets and human serum samples, and evaluated statistically to assess the application of the method. The method was validated under ICH and USP guidelines and was found to comprise the advantages for simplicity, stability, sensitivity, reproducibility, and accuracy for use as an alternative to existing nonspectrophotometric methods for the routine determination of the drug in pharmaceutical formulations and for pharmaceutical investigations involving simvastatin.

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Authors and Affiliations

  1. Department of Chemistry, University of Karachi, Karachi, 75270, Pakistan

    M. S. Arayne

  2. Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, University of Karachi, Karachi, 75270, Pakistan

    N. Sultana & S. A. Ali

  3. Quality Control Department, Noa Hemis Pharmaceuticals, 154/23, Korangi Industrial Area, Karachi, 74900, Pakistan

    F. Hussain

Authors
  1. M. S. Arayne
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  2. N. Sultana
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  3. F. Hussain
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  4. S. A. Ali
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Arayne, M.S., Sultana, N., Hussain, F. et al. Validated spectrophotometric method for quantitative determination of simvastatin in pharmaceutical formulations and human serum. J Anal Chem 62, 536–541 (2007). https://doi.org/10.1134/S106193480706007X

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  • DOI: https://doi.org/10.1134/S106193480706007X

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