Journal: Journal of Pharmacy Research

Article Id: JPRS-PCS-00003325
Title: Development and validation of a sensitive RP-HPLC method for quantitative determination of imatinib mesylate in complex dosage forms like drug eluting coronary stents
Category: Pharmaceutics
Section: Research Article
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    Aim: The present study is aimed to develop and validate an accurate, precise, and simple reversed-phase–high-performance liquid chromatography (HPLC) method for the estimation of imatinib mesylate (IM) released from the IM-coated stents. Materials and Methods: Different chromatographic conditions were tried for IM separation in the placebo (uncoated stents) and validated as per ICH guidelines. The validated HPLC method is applied to measure IM released from IM-coated stents. Results: The chromatographic separation was achieved on C18 column (250 mm × 4.6 mm i.e., 5 μm) with a mobile phase consisting of methanol-water-glacial acetic acid (65:35:0.03%, v/v) at a flow rate of 1.0 ml/min. Detection was carried out at 267 nm with photodiode array detector and IM eluted at 5.02 min (retention time) with no interfering peak of excipients used for the preparation of dosage form. The method was linear over the range from 0.3 to 9 μg/mL (R2 = 0.999). The intraday and interday precision values were <2%. Limit of detection and limit of quantitation were 0.2 μg/mL and 0.5 μg/mL, respectively. Conclusion: The method validated according to ICH guidelines and successfully applied for quantitative analysis and release studies of complex pharmaceutical dosage form like IM-coated stent.

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    Author(s) Name:

    Prashanth Srirangam1 *, V. Jagannath Patro2 , Ganapathi Seru3

    Affiliation(s) Name:

    1 Department of Pharmacology, Browns College of Pharmacy, Khammam, Telangana, India,

    2 Browns College of Pharmacy, Khammam, Telangana, India,

    3 Gitam Institute of Pharmacy, Gitam University, Visakhapatnam, Andhra Pradesh, India

    *Corresponding author: Prashanth Srirangam, Department of Pharmacology, Browns College of Pharmacy, Khammam, Telangana, India.

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    Author:

    Prashanth Srirangam1 *, V. Jagannath Patro2 , Ganapathi Seru3

    Title:Development and validation of a sensitive RP-HPLC method for quantitative determination of imatinib mesylate in complex dosage forms like drug eluting coronary stents
    Journal:Journal of Pharmacy Research
    Vol(issue):13 (March )
    Year:2019
    Page No: (15-19)
  • Experimental Methods Keywords

    Methodology: High-performance liquid chromatography
    Research Materials:imatinib mesylate

Keywords

High-performance liquid chromatography Imatinib mesylate Phosphate buffer saline Polylactic-co-glycolic acid

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