Abstract

<p class="Default"><strong>Objective: </strong>The present study was aimed to develop a rapid, accurate, linear, sensitive and stability-indicating high performance liquid chromatographic method for determination of curcumin and to implement the developed method for the estimation of curcumin in the nanoparticulate formulation.</p><p class="Default"><strong>Methods: </strong>Method development was performed using various solvent, buffer-solvent ratios, at different flow rates for better resolution and to decrease the run time. The developed method was validated in accordance with the international conference on harmonization (ICH) guidelines. The developed method was implemented to estimate the amount of curcumin in the curcumin-nanoparticulate formulation.</p><p class="Default"><strong>Results: </strong>The optimum chromatographic conditions with adequate resolution for curcumin (16.10 min) was achieved when the separation was carried using C<sub>18 </sub>column at ambient temperature with an isocratic elution mode of mobile phase composed of a degassed mixture of phosphate buffer pH 3 and acetonitrile (50:50 v/v) at 1.0 ml/min flow rate with a total run time of 20 min. The developed method was validated for system suitability, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), linearity and range. The LOD and LOQ were found to be 0.018 and 0.056 μg/ml respectively, which indicates that the method was sensitive, and can detect and quantify at lower levels of curcumin. Linearity range was from 5-15 μg/ml for curcumin with regression coefficient 0.997 indicates that at this concentration range curcumin was highly linear. Percent assay of curcumin was found to be 98.7% and curcumin recovered was found to be 0.78 mg which are estimated by using the developed method.</p><p class="Default"><strong>Conclusion: </strong>The developed analytical method is simple, precise, and reproducible and thus can be used for stability-indicating analysis of curcumin in pharmaceutical formulations.</p>

Highlights

  • Curcumin is a hydrophobic polyphenolic substance isolated from the rhizomes of Curcuma longa Linn

  • The optimum chromatographic condition with adequate resolution for curcumin was achieved when the separation was carried using enable C18 column (250 mm x 4.6 mm, 5μ) at ambient temperature with an isocratic elution mode of mobile phase composed of a degassed mixture of acetonitrile: phosphate buffer pH 3 (50:50 v/v) at 1.0 ml/min flow rate with a total run time of 20 min

  • The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.018 and 0.056 μg/ml, respectively, which indicates that the method was sensitive, and can detect and quantify at lower levels of curcumin

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Summary

Introduction

Curcumin is a hydrophobic polyphenolic substance isolated from the rhizomes of Curcuma longa Linn. It is available in the market as a mixture of three different constituents, commonly known as curcuminoids [1, 2, 3]. Safety of curcumin at very high doses has been proved in various animal and human studies. These studies led to the approval of curcumin as a ‘Generally Regarded as Safe (GRAS)’ ingredient by the Food and Drug Administration (FDA) of the United States of America, by the Natural health products directorate of Canada and the Expert Joint Committee of the Food and Agriculture Organization/ World Health Organization (FAO/WHO) on food additives (JECFA) [7]

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