Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-00001466
Title: Sensitive Analytical Method Development and Validation of Simvastatin Bulk Drug by RP-HPLC
Category: Pharmaceutics
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    This paper describes the analytical method suitable for validation of Simvastatin by reversed Phase High Performance liquid chromatography (RP-HPLC) method. The method utilized RP-HPLC (Younglin HPLC with UV-detector) model and a column, 150mm  4.6 mm, 5m (Symmetry, ODS- 3V, 150mm ´ 4.6mm, 5m). The mobile phases were comprised of Acetonitrile and (0.02M) Buffer pH 3.5 (60:40 v/v). Validation experiments were performed to demonstrate System suitability, precision, linearity and Range, Accuracy study, stability of analytical solution and robustness. The method was linear over the concentration range of 1-150 mg/ML-1. The method showed good recoveries (98.2 – 104.3%).

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    Author(s) Name:

    Madhukar. A1*, V. Swapna3, K. Nagasree2, S. Spoorthi2, B. Uma Maheshwari2

    Affiliation(s) Name:

    1Bright Labs, Kothapet, Hyderabad, A. P, India
    2St. Mary’s College of Pharmacy, Secunderabad, A. P, India
    3Institute of Science and Technology (JNTU), Hyderabad, A. P, India

    *Corresponding author.
    Madhukar. A
    Bright Labs, Kothapet,
     Hyderabad,
    A. P, India

    Received on:10-11-2011; Revised  on: 15-12-2011; Accepted on:12-01-2012

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    Author:

    Madhukar. A1*, V. Swapna3, K. Nagasree2, S. Spoorthi2, B. Uma Maheshwari2

    Title:Sensitive Analytical Method Development and Validation of Simvastatin Bulk Drug by RP-HPLC
    Journal:Journal of Pharmacy Research
    Vol(issue):5(2)
    Year:2012
    Page No: (906-907)
  • Experimental Methods Keywords

    Methodology:RP-HPLC analysis, Analytical method development, Quality control, validation.
    Research Materials:Simvastatin

Keywords

RP-HPLC Simvastatin Analytical method Quality control validation.

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