Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-00001344
Title: Analytical method development and validation of aliskiren in bulk and tablet dosage form by RP- HPLC method
Category: Pharmaceutics
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    A simple, accurate, precise, and reproducible reverse phase liquid chromatographic method developed and validated for the quantification of Aliskiren in bulk drug and in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a PhenomenaxLunaC18 (ODS) column (150 X 4.6 mm i.d., particle size 5m). The mobile phase consisting of phosphate buffer pH 3.0: Acetonitrile (60:40, v/v). An isocratic elution was achieved at a flow rate of 1 ml/ min at ambient temperature. The detection was carried out at 293nm using Shimadzu UV-Visible detector SpD-10AVP. The retention time of Aliskiren was found to be 5.02 min. The calibration curve was linear in the concentration range of 5-30mg/ ml (r2- 0.9999).The limit of detection and the limit of quantification were found to be 0.580531 mg/ml and 1.75918mg/ml respectively. The amount of Aliskiren present in the formulation (Tekturna) was found to be 99.79 ± 0.8075. The method was validated statistically using the SD, %RSD and SE and the values were found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 101.10±1.635%. So, the proposed method was found to be simple, specific, linear, and rugged. Hence it can be applied for routine analysis of Aliskiren in bulk and pharmaceutical formulation.

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    Author(s) Name:

    G. Kumara Swamy 1*, J.V.L.N Sheshagiri Rao3, J.M.Rajendra Kumar2,U.Ashok Kumar1, D.V.R.N. Bikshapathi1 , D.Vinay kumar4

    Affiliation(s) Name:

    1Department of Pharmaceutical Analysis, Trinity College of Pharmaceutical sciences, Peddapalli, Karimnagar (dist) - 505172.Andhra Pradesh.
    2Holy Mary Institute of Science and Technology,Ghatkesar, Hyderabad,Andhra Pradesh.
    3University College of pharmaceutical sciences, Andhra University,Visakhapatnam,530 003. Andhra Pradesh.
    4School of Pharmacy. JNTU Kakinada, Andhra Pradesh.

    *Corresponding author.
    G. Kumara Swamy
    Department of Pharmaceutical Analysis, Trinity
    College of Pharmaceutical sciences,
    Peddapalli,
    Karimnagar (dist) - 505172.A.P.


    .Received on: 05-10-2010; Revised on: 14-12-2010; Accepted on:09-02-2011

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    Author:

    G. Kumara Swamy 1*, J.V.L.N Sheshagiri Rao3, J.M.Rajendra Kumar2,U.Ashok Kumar1, D.V.R.N. Bikshapathi1 , D.Vinay kumar4

    Title:Analytical method development and validation of aliskiren in bulk and tablet dosage form by RP- HPLC method
    Journal:Journal of Pharmacy Research
    Vol(issue):4 (March)
    Year:2011
    Page No: (0-0)
  • Experimental Methods Keywords

    Methodology:RP-HPLC Method, Validation, System suitability tests.
    Research Materials:Aliskiren

Keywords

Aliskiren RP-HPLC Method Validation System suitability tests.

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