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Published on:June 2017
Indian Journal of Pharmaceutical Education and Research, 2017; 51(3):388-392
Original Article | doi:10.5530/ijper.51.3.65

Applications of New Validated RP-HPLC Method for Determination of Indomethacin and its Hydrolytic Degradants using Sodium Acetate Buffer


Authors and affiliation (s):

Sanjay Pai* and Neelam Sawant

Department of Quality Assurance, Goa College of Pharmacy,18th June Road, Panaji, Goa – 403 001, India

Abstract:

Objective: A New RP-HPLC method for estimation of indomethacin and its two degradant impurities 4-chlorobenzoic acid, 5-methoxy-2-methyl-indoleacetic acid was developed and validated as per ICH guidelines. Background: This new method is not only capable of identifying and quantifying the impurities but also can be used for the assay of indomethacin in marketed capsule formulations. Methods: The chromatographic conditions were optimized using Zorbax Eclipse Plus C18, 3.5 μm (4.6 mm × 100 mm) column with methanol: acetonitrile: 10 mM sodium acetate buffer pH 3, 10:50:40% v/v as the mobile phase at the flow rate of 1 ml/min and detection was carried out using UV-Visible PDA detector at 254 nm. Results: The method was linear over concentration range of 25-70 μg/ml for indomethacin, 0.25-2 μg/ml for 4-chlorobenzoic acid and 0.25- 2 μg/ml for 5-methoxy-2-methyl-indoleacetic acid. The developed method was validated as per the ICH guidelines for linearity, accuracy, precision, limit of detection, limit of quantification, robustness and specificity for indomethacin and its impurities.

Key words: RP-HPLC, Indomethacin, 4-chlorobenzoic acid, 5-methoxy-2-methylindoleacetic acid, Validation

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs