Journal: JPR:BioMedRx:An International Journal

Article Id: JPRS-DVD-0000249
Title: Development and validation of a stability-indicating RP-HPLC method for estimation of Ciclopirox olamine in bulk drug and cream formulation
Category: Development and Validation of Drugs
Section: Research Article
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    A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for estimation of ciclopirox olamine (CPO) both in bulk drug and in cream formulation. Reversed-phase chromatography was performed on a phenomenex C18 column with mobile phase acetonitrile-phosphate buffer 6.5 pH (70:30 v/v) at a flow rate of 1.0 ml min-1. Detection was performed at 305 nm and a sharp peak was obtained for CPO at a retention time of 7.190 ± 0.045 min. The method was validated for accuracy, precision, specificity and selectivity, robustness, detection and quantification limits, and system suitability in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed there was a good linear relationship between response and concentration in the range 2 - 16 μg ml-1; the regression coefficient was 0.9980 and the linear regression equation was y = 10035x - 20400. The detection (LOD) and quantification (LOQ) limits were found to be 0.005 and 0.01 μg ml-1, respectively. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of CPO. In order to determine whether the analytical method and assay were stability-indicating, CPO cream was stressed under various conditions to conduct forced degradation studies. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of CPO with high precision and accuracy.

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    Author(s) Name:

    Bhavik H Satani*1, Jayesh V Patel2,a, Rajesh B Gami3, Chhaganbhai N Patel

    Affiliation(s) Name:

    1 Maliba Pharmacy College, Tarsadi, Bardoli-394350, Gujarat, India.
    2 Shri Sarvajanic Pharmacy College, Mehsana-384001, Gujarat, India.
    a Food And Drug Control Administration, Gujarat, India.
    3 L. J. Institute of Pharmacy, Ahmedabad-382210., Gujarat, India

    *Corresponding author.
    Bhavik H Satani,
    Maliba Pharmacy College,
    Gopalvidyanagar, Tarsadi,
    Bardoli-394350, India.


    Received on:17-09-2012; Revised on: 19-10-2012; Accepted on:10-12-2012

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    Author:

    Bhavik H Satani*1, Jayesh V Patel2,a, Rajesh B Gami3, Chhaganbhai N Patel

    Title:Development and validation of a stability-indicating RP-HPLC method for estimation of Ciclopirox olamine in bulk drug and cream formulation
    Journal:JPR:BioMedRx:An International Journal
    Vol(issue):1 (January )
    Year:2013
    Page No: (102-108)
  • Experimental Methods Keywords

    Methodology:RP-HPLC method
    Research Materials:Ciclopirox olamine

Keywords

stability-indicating; reversed-phase chromatography; ciclopirox olamine; forced degradation studies; cream formulation

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